Substantially Equivalent 510(k) Device Applications
Alphabetical Listing by Applicant Name
Information updated through August 31, 2008
BK980025 5D Information Management
Suite 500, 10025 - 102A Avenue
Edmonton, Alberta Canada T5J 2Z2
Trade Name:Plasma Center Module - 1.0
Cleared Date: 18-MAY-1999
Cleared Under Fifth Dimension Information
Systems
BK990022 5D Information Management
Suite 500, 10025 - 102A Avenue
Edmonton, Alberta Canada T5J 2Z2
Trade Name:Donor Management System - 1.0.0
Cleared Date: 10-SEP-1999
Cleared Under Fifth Dimension Information
Systems
BK000026 5D Information Management
Suite 500, 10025 - 102A Avenue
Edmonton, Alberta Canada T5J 2Z2
Trade Name:P2K Plasma Center Module 2000 -
1.0
Cleared Date: 22-JUN-2000
Cleared Under Fifth Dimension Information
Systems
BK020058 5D Information Management
Suite 500, 10025 - 102A Avenue
Edmonton, Alberta Canada T5J 2Z2
Trade Name:LOGIC - 1.0
Cleared Date: 03-FEB-2003
Cleared Under Fifth Dimension Information
Systems
BK040040 5D Information Management
Suite 500, 10025 - 102A Avenue
Edmonton, Alberta Canada T5J 2Z2
Trade Name:LOGIC - 2.0
Cleared Date: 06-OCT-2004
Cleared Under Fifth Dimension Information
Systems
BK050060 5D Information Management
Suite 500, 10025 - 102A Avenue
Edmonton, Alberta Canada T5J 2Z2
Trade Name:E-Interview (eQue) - 1.0.0
Cleared Date: 24-MAY-2006
Cleared Under Fifth Dimension Information
Systems
BK060051 5D Information Management
Suite 500, 10025 - 102A Avenue
Edmonton, Alberta Canada T5J 2Z2
Trade Name:HaemoConnect (eLynx) - 1.0.0
Cleared Date: 06-MAR-2008
BK070011 ABSORBER AB
Drottninggatan 33
Stockholm, Sweden SE-103 95
Trade Name:XM-ONE Transplantation Cross Match
Cleared Date: 29-JUL-2008
BK960027 ADAC HealthCare Information System
5 Greenway Plaza
Suite 1900
Houston, TX 77046
Trade Name:ADAC Blood Bank System
Cleared Date: 12-AUG-1998
BK050005 ALBA Bioscience
21 Ellen's Glen Road
Liberton, Edinburgh
EH17 7QT
Scotland, UNITED KINGDOM, United
Kingdom EH17 7QT
Trade Name:Quant-Rho FITC Anti-D for Fetal
Cell Assay
Cleared Date: 27-SEP-2005
BK070033 ALBA Bioscience
21 Ellen's Glen Road
Liberton, Edinburgh
EH17 7QT
Scotland, UNITED KINGDOM, United
Kingdom EH17 7QT
Trade Name:AlbaQ-Chek Simulated Whole Blood
Controls
Cleared Date: 27-JUL-2007
BK080027 ALBA Bioscience
21 Ellen's Glen Road
Liberton, Edinburgh
EH17 7QT
Scotland, UNITED KINGDOM, United
Kingdom EH17 7QT
Trade Name:ALBAcheck - BGS Reagent Control
for Anti-D
Cleared Date: 29-JUL-2008
BK870009 ARK-Bio-Medical Canada Corp.
#671 Rustico Road
Winsloe, Canada CIE 1Z2
Trade Name:WesLabs Model 601
Cleared Date: 15-NOV-1989
Cleared Under Rush Enterprises, Inc.
BK950048 Abbott Laboratories
100 Abbott Park Road
Abbott Park, IL 60064-3500
Trade Name:Abbott Apheresis Results Tracking
System/AARTS
Cleared Date: 24-JUN-1998
BK950052 Abbott Laboratories
100 Abbott Park Road
Abbott Park, IL 60064-3500
Trade Name:Abbott DMS II Data Management
System
Cleared Date: 12-AUG-1998
BK970042 Abbott Laboratories
100 Abbott Park Road
Abbott Park, IL 60064-3500
Trade Name:ABBOTT PRISM System
Cleared Date: 14-JUN-1999
BK010036 Abbott Laboratories
100 Abbott Park Road
Abbott Park, IL 60064-3500
Trade Name:ABBOTT PRISM Retest Server - 1.0
Cleared Date: 17-JUL-2002
BK060028 Abbott Laboratories
100 Abbott Park Road
Abbott Park, IL 60064-3500
Trade Name:Abbott PRISM Retest Server
Cleared Date: 07-JUN-2006
BK080015 Abbott Laboratories
100 Abbott Park Road
Abbott Park, IL 60064-3500
Trade Name:ABBOTT PRISM Director V2.0
Cleared Date: 24-APR-2008
BK810599 Accugenics, Inc.
Costa Mesa, CA 92626
Trade Name:Dade Rh Control Reagent
Cleared Date: 31-MAR-1981
BK820004 Accugenics, Inc.
Costa Mesa, CA 92626
Trade Name:Trans-Type Reagents
Cleared Date: 29-OCT-1982
BK830001 Accugenics, Inc.
Costa Mesa, CA 92626
Trade Name:Polycation Potentiator System
Cleared Date: 06-MAY-1983
BK860038 Accugenics, Inc.
Costa Mesa, CA 92626
Trade Name:Data-Fi Thrombin Reagent
Cleared Date: 16-JAN-1987
BK890018 Ackrad Laboratories
70 Jackson Dr.
Cranford, NJ 07016
Trade Name:Ackrad Blood Warming Assembly
Cleared Date: 21-SEP-1990
BK960071 AcroMetrix Corporation
6058 Egret Court
Benicia, CA 94510
Trade Name:ViroSure Multi-Marker
Cleared Date: 11-FEB-1998
BK040060 AcroMetrix Corporation
6058 Egret Court
Benicia, CA 94510
Trade Name:VeriSure Pro External Quality
Controls
Cleared Date: 03-MAY-2005
BK050061 AcroMetrix Corporation
6058 Egret Court
Benicia, CA 94510
Trade Name:VeriSure Pro WNV RNA Negative
External Quality Control
VeriSure Pro WNV RNA Positive
External Quality Control
VeriSure Pro West Nile Virus (WNV)
RNA External Quality Controls:
Cleared Date: 21-DEC-2005
BK060064 AcroMetrix Corporation
6058 Egret Court
Benicia, CA 94510
Trade Name:VeriSure Pro HBV DNA External
Quality Control
Cleared Date: 08-FEB-2007
BK960002 Activated Cell Therapy Inc.
291 North Bernardo Avenue
Mountain View, CA 94043
Trade Name:ACT Buoyant Density Solution
Cleared Date: 12-AUG-1996
BK940054 Alpha Scientific Corporation
P.O. Box 725
Southeastern, PA 19399
Trade Name:SEG-Safe (TM)
Cleared Date: 15-MAR-1995
BK950014 Alpha Scientific Corporation
P.O. Box 725
Southeastern, PA 19399
Trade Name:SEG-SAFE
Cleared Date: 31-MAR-1995
BK860014 Alpha Therapeutic Corporation
5555 Valley Boulevard
Los Angeles, CA 90032
Trade Name:JMS Double Blood Collection Pack
Cleared Date: 04-JUN-1986
BK870004 Alpha Therapeutic Corporation
5555 Valley Boulevard
Los Angeles, CA 90032
Trade Name:Plasma Transfer Pack
Cleared Date: 11-MAR-1987
BK950044 Alpha Therapeutic Corporation
13111 Temple Avenue
City of Industry, CA 91746
Trade Name:Transfer Device
Cleared Date: 18-OCT-1995
BK950021 Alton Dean Medical, Inc.
1547 West 2290 South
Woods Cross, UT 84087
Trade Name:Alton Dean Model FW-437
Cleared Date: 15-MAY-1995
BK960030 American Blood Resources Association
PO Box 669
Annapolis, MD 21404
Trade Name:National Donor Deferral Registry
Cleared Date: 20-MAR-1997
BK010012 American Blood Resources Association
147 Old Solomons Island Rd.
Annapolis, MD 21401
Trade Name:National Donor Deferral Registry
(NDDR) - 1.0
Cleared Date: 06-SEP-2001
BK960040 American Red Cross
National Headquarters
Washington, DC 20006
Trade Name:NBCS 1.1
Cleared Date: 28-FEB-1997
BK820016 American Red Cross Blood Services
15601 Crabbs Branch Way
Rockville, MD 20855
Trade Name:ARC HLA Extended Trays
ARC HLA Trays
Cleared Date: 01-JUN-1983
BK840015 American Red Cross Blood Services
15601 Crabbs Branch Way
Rockville, MD 20855
Trade Name:Bovine Albumin 3%
Cleared Date: 25-OCT-1984
BK880021 American Red Cross Blood Services
15601 Crabbs Branch Way
Rockville, MD 20855
Trade Name:Frozen-Dried Bromelein
Cleared Date: 21-DEC-1988
BK020032 American Red Cross Blood Services
Quality and Regulatory Affairs
1616 Fort Myer Drive
Arlington, VA 22209
Trade Name:NGTL Automation System (NAS) -
5.2.0
Cleared Date: 20-MAR-2003
BK850010 Amtec Diagnostics International Inc.
1107 IH-45 South
Conroe, TX 77305
Trade Name:Rh-Hr Control
Cleared Date: 27-DEC-1985
BK850023 Amtec Diagnostics International Inc.
1107 IH-45 South
Conroe, TX 77305
Trade Name:Amtec CM-Tec Control
Cleared Date: 30-DEC-1985
BK860002 Amtec Diagnostics International Inc.
1107 IH-45 South
Conroe, TX 77305
Trade Name:Bovine Albumin 22%
Cleared Date: 03-MAR-1986
BK860003 Amtec Diagnostics International Inc.
1107 IH-45 South
Conroe, TX 77305
Trade Name:Bovine Albumin 30%
Cleared Date: 03-MAR-1986
BK860008 Amtec Diagnostics International Inc.
1107 IH-45 South
Conroe, TX 77305
Trade Name:Amtec Anti-A1 Lectin
Cleared Date: 16-JUN-1986
BK860009 Amtec Diagnostics International Inc.
1107 IH-45 South
Conroe, TX 77305
Trade Name:Amtec Anti-N Lectin
Cleared Date: 18-SEP-1987
BK860010 Amtec Diagnostics International Inc.
1107 IH-45 South
Conroe, TX 77305
Trade Name:Amtec PS
Cleared Date: 16-DEC-1986
BK860020 Amtec Diagnostics International Inc.
1107 IH-45 South
Conroe, TX 77305
Trade Name:Amtec R-E-S System
Cleared Date: 25-FEB-1987
BK860021 Amtec Diagnostics International Inc.
1107 IH-45 South
Conroe, TX 77305
Trade Name:Amtec Coombs Control Cells
Cleared Date: 26-AUG-1986
BK860026 Amtec Diagnostics International Inc.
1107 IH-45 South
Conroe, TX 77305
Trade Name:Amtec Anti-H Lectin
Cleared Date: 27-JAN-1987
BK860036 Amtec Diagnostics International Inc.
1107 IH-45 South
Conroe, TX 77305
Trade Name:Model Series, Mini & BB
Cleared Date: 24-FEB-1987
BK870020 Amtec Diagnostics International Inc.
1107 IH-45 South
Conroe, TX 77305
Trade Name:Amtec Ficin System
Cleared Date: 02-FEB-1988
BK010024 Applied Biosystems
850 Lincoln Centre Drive
Foster City, CA 94404
Trade Name:ViroSeq HIV-1 Genotyping System
Cleared Date: 10-DEC-2002
BK030005 Applied Biosystems
1401 Harbor Bay Parkway
Alameda, CA 94502
Trade Name:ViroSeq HIV-1 Genotyping System
Cleared Date: 29-JAN-2003
BK010031 Applied Science, Inc.
964-B Golden Gate Terrace
Grass Valley, CA 95945
Trade Name:Hemoflow Model 400 with Data
Scanner
Cleared Date: 23-JAN-2002
BK990011 Applied Sciences, Inc.
964-B Golden Gate Terrace
Grass Valley, CA 95945
Trade Name:HemoFlow Donor Monitor
Cleared Date: 16-JUL-1999
BK990019 Applied Sciences, Inc.
964-B Golden Gate Terrace
Grass Valley, CA 95945
Trade Name:HemoFlow Donor Monitor and Mixer
Cleared Date: 05-OCT-1999
BK020031 Arlington Scientific, Inc.
1840 North Technology Dr.
Springville, UT 84663
Trade Name:ASI TPHA Test
Cleared Date: 30-JAN-2003
BK940022 Arrow International, Inc.
P.O.Box 12888 3000 Bernville Road
Reading, PA 19612
Trade Name:Arrow Qwik-1 TM Blood and Fluid
Administration Set
Cleared Date: 14-JUL-1994
BK910017 Assoc. of Cape Cod
P.O. Box 224
Woods Hole, MA 02543
Trade Name:Control Standard
Endotoxin/Pepyrogeneration Valid.
Cleared Date: 21-OCT-1991
BK940032 Augustine Medical, Inc.
10393 West 70 th Street
Eden Prairie, MN 55344
Trade Name:Bair Hugger Patient Warming Device
Cleared Date: 29-SEP-1994
BK930027 BBI Diagnostics, A SeraCare Company
375 West Street
West Bridgewater, MA 02379
Trade Name:Accurun 1
Cleared Date: 25-OCT-1994
Cleared Under Boston Biomedica, Inc.
BK970004 BBI Diagnostics, A SeraCare Company
375 West Street
West Bridgewater, MA 02379
Trade Name:ACCURUN155
Cleared Date: 23-APR-1999
Cleared Under Boston Biomedica, Inc.
BK990032 BBI Diagnostics, A SeraCare Company
375 West Street
West Bridgewater, MA 02379
Trade Name:Accurun 106 HIV-1 Antigen
Cleared Date: 20-JAN-2000
Cleared Under Boston Biomedica, Inc.
BK010038 BBI Diagnostics, A SeraCare Company
375 West Street
West Bridgewater, MA 02379
Trade Name:Accurun 1 Multimarker Negative
Control
Cleared Date: 18-DEC-2001
Cleared Under Boston Biomedica, Inc.
BK040006 BBI Diagnostics, A SeraCare Company
375 West Street
West Bridgewater, MA 02379
Trade Name:ACCURUN 315 HIV-1 RNA Positive
Control
Cleared Date: 12-OCT-2004
Cleared Under Boston Biomedica, Inc.
BK040016 BBI Diagnostics, A SeraCare Company
375 West Street
West Bridgewater, MA 02379
Trade Name:ACCURUN 305 HCV RNA Positive
Quality Control
Cleared Date: 17-DEC-2004
Cleared Under Boston Biomedica, Inc.
BK040064 BBI Diagnostics, A SeraCare Company
375 West Street
West Bridgewater, MA 02379
Trade Name:ACCURUN 345 HIV-1 RNA, HCV RNA,
HBV DNA Positive Quality Control
Series 150
Cleared Date: 29-OCT-2004
Cleared Under Boston Biomedica, Inc.
BK040067 BBI Diagnostics, A SeraCare Company
375 West Street
West Bridgewater, MA 02379
Trade Name:ACCURUN 803 Nucleic Acid Negative
Quality Control (HIV, HCV, HBV)
Cleared Date: 19-NOV-2004
Cleared Under Boston Biomedica, Inc.
BK060022 BBI Diagnostics, A SeraCare Company
375 West Street
West Bridgewater, MA 02379
Trade Name:ACCURUN 365 West Nile Virus RNA
Positive Quality Control
Cleared Date: 12-JUN-2006
BK060030 BBI Diagnostics, A SeraCare Company
375 West Street
West Bridgewater, MA 02379
Trade Name:ACCURUN 804 Nucleic Acid Negative
Quality Control (HIV, HCV, HBV,
WNV)
Cleared Date: 18-AUG-2006
BK030027 BD Biosciences
2350 Qume Drive
San Jose, CA 95131-1807
Trade Name:BD IMAGN Microvolume Fluorimeter
and BD IMAGN rWBC Assay Kit
Cleared Date: 10-JUL-2003
BK050062 BD Biosciences
2350 Qume Drive
San Jose, CA 95131-1807
Trade Name:BD HLA-B27 kit
Cleared Date: 27-OCT-2005
BK050073 BD Biosciences
2350 Qume Drive
San Jose, CA 95131-1807
Trade Name:BD HLA-B27 System
Cleared Date: 16-FEB-2006
BK980011 BECTON DICKINSON VACUTAINER Systems
1 Becton Drive
Franklin Lakes, NJ 07417
Trade Name:VACUTAINER Brand PLUS (Plastic)
Blood Collection Tube with EDTA
Anticoagulant
Cleared Date: 07-JUN-1999
BK820008 BMT Incorporated
7315 Hazeltine Boulevard
Excelsior, MN 55331
Trade Name:BMT Model 24 Bloodmixer
Cleared Date: 22-OCT-1982
BK940031 Bard Radiology
10115 Highway 142
Covington, GA 30209
Trade Name:True-Pulse Infusion Catheter
Cleared Date: 27-APR-1995
BK900010 Baxter Healthcare Corporation
1851 Delaware Parkway
Miami, FL 33152
Trade Name:Dade Chemically Modified Control
Reagent
Cleared Date: 21-SEP-1990
BK920025 Baxter Healthcare Corporation
1 Baxter Pkwy.
Deerfield, IL 60015
Trade Name:Dade Fetal-Cyte Screening Kit
Cleared Date: 05-AUG-1993
BK940062 Baxter Healthcare Corporation
1 Baxter Pkwy.
Deerfield, IL 60015
Trade Name:Cryocyte TM
Cleared Date: 27-DEC-1994
BK950049 Baxter Healthcare Corporation
9 Parker
Irvine, CA 92618
Trade Name:Cryocyte Freezing Container
Cleared Date: 14-FEB-1996
BK960010 Baxter Healthcare Corporation
9 Parker
Irvine, CA 92618
Trade Name:Cell Wash Set
Cleared Date: 22-MAY-1996
BK020002 Baxter Healthcare Corporation
550 North Brand Blvd.
Glendale, CA 91203
Trade Name:Serology SQL LIMS - 1.0
Cleared Date: 07-AUG-2002
BK020059 Baxter Healthcare Corporation
25212 West ILL Route 120
RoundLake, IL 60073
Trade Name:ALYX Component Collection System
Cleared Date: 23-JAN-2003
BK030052 Bayer HealthCare Diagnostics Division
700 BAY Street, Suite 1000
Toronto, Ontario M5G 1Z6 Canada
Trade Name:TRUGENE HIV-1 Genotyping Kit and
OpenGene DNA Sequencing System
Cleared Date: 08-OCT-2003
BK040052 Bayer HealthCare Diagnostics Division
700 BAY Street, Suite 1000
Toronto, Ontario M5G 1Z6 Canada
Trade Name:TRUGENE HIV-1 Genotyping Kit and
OpenGene DNA Sequencing System
Cleared Date: 15-OCT-2004
BK050035 Bayer HealthCare Diagnostics Division
P.O. Box 2466
Berkeley, CA 94702-5828
Trade Name:TRUGENE HIV-1 Genotyping Kit and
OpenGene DNA Sequencing System
Cleared Date: 20-SEP-2005
BK010044 Beckman Coulter, Inc.
11800 SW 147 Avenue
(M/C: 31-B06)
Miami, FL 33196-2500
Trade Name:stemONE System for EPICS XL/ XL-
MCL Flow Cytometry Systems
Cleared Date: 20-MAY-2002
BK020063 Beckman Coulter, Inc.
11800 SW 147 Avenue
(M/C: 31-B06)
Miami, FL 33196-2500
Trade Name:LeukoSure Enumeration Kit with
Leuko-Trol RBC Control Cells and
Leuko Trol Platelet Control Cells
Cleared Date: 03-FEB-2003
BK040032 Beckman Coulter, Inc.
11800 SW 147 Avenue
(M/C: 31-B06)
Miami, FL 33196-2500
Trade Name:Stem-Kit Reagents
Cleared Date: 05-MAY-2004
BK040055 Beckman Coulter, Inc.
11800 SW 147 Avenue
(M/C: 31-B06)
Miami, FL 33196-2500
Trade Name:stemCXP System for the FC 500 with
CXP Software
Cleared Date: 16-SEP-2004
BK930010 Becton Dickinson Immunocytometry Systems
2350 Qume Drive
San Jose, CA 95131
Trade Name:HLA-B27 Screening Systems
Cleared Date: 09-SEP-1993
BK940015 Becton Dickinson Immunocytometry Systems
2350 Qume Drive
San Jose, CA 95131
Trade Name:The HLA-B27 System
Cleared Date: 24-OCT-1994
BK960087 Becton Dickinson Immunocytometry Systems
2350 Qume Drive
San Jose, CA 95131
Trade Name:ProCount Progenitor Cell
Enumeration Kit
Cleared Date: 04-JUN-1998
BK970038 Becton Dickinson Immunocytometry Systems
2350 Qume Drive
San Jose, CA 95131
Trade Name:Procount Software
Cleared Date: 04-FEB-1999
BK970046 Becton Dickinson Immunocytometry Systems
2350 Qume Drive
San Jose, CA 95131
Trade Name:LeucoCOUNT Reagent
Cleared Date: 14-AUG-1998
BK950068 Becton, Dickinson & Company
1 Becton Drive, MC 300
Franklin Lakes, NJ 07417-1885
Trade Name:CMV Scan Card Test
Cleared Date: 22-DEC-1995
BK040030 Becton, Dickinson & Company
1 Becton Drive, MC 300
Franklin Lakes, NJ 07417-1885
Trade Name:BD Vacutainer Plus Plastic Serum
Tubes with Clot Activator
Cleared Date: 05-MAY-2004
BK050036 Becton, Dickinson & Company
1 Becton Drive, MC 300
Franklin Lakes, NJ 07417-1885
Trade Name:BD Vacutainer Plus K2EDTA Tubes
BD Vacutainer Plus Serum Tubes
BD Vacutainer SST Glass Tubes
BD Vacutainer SST II Advance Tubes
BD Vacutainer SST Plus Tubes
Cleared Date: 24-FEB-2006
BK060046 Becton, Dickinson & Company
1 Becton Drive, MC 300
Franklin Lakes, NJ 07417-1885
Trade Name:Bd.id Patient Identification
System for Transfusion Management
- V7.00
Cleared Date: 13-FEB-2007
BK960001 Behring Diagnostics
175 University Avenue
Westwood, MA 02090
Trade Name:OPUS CMV
Cleared Date: 09-OCT-1996
BK970035 BioAccess, Inc.
8400 Cedar Street
Silver Spring, MD 20910
Trade Name:Bioaccess Marrow Collection System
Cleared Date: 23-DEC-1998
BK000046 BioE, Inc.
4280 Centerville Road
St. Paul, MN 55127
Trade Name:FluoroTrol Control Kits
Cleared Date: 02-APR-2001
Cleared Under BioErgonomics, Inc.
BK050029 BioLife Plasma Services LP
One Baxter Parkway
Deerfield, IL 60015
Trade Name:Donor Information System (DIS) -
3.1
Cleared Date: 07-JUL-2005
BK060017 BioLife Plasma Services LP
One Baxter Parkway
Deerfield, IL 60015
Trade Name:Donor Information System (DIS) -
3.2
Cleared Date: 09-MAY-2006
BK080016 BioLife Plasma Services LP
One Baxter Parkway
Deerfield, IL 60015
Trade Name:Donor Information System - v3.3
Cleared Date: 02-JUL-2008
BK970017 BioMerieux
1022 Hingham Street
Rockland, MA 02370
Trade Name:HLA-DR Oligo Detection Kit
Cleared Date: 28-MAY-1998
BK860005 BioMerieux, Inc.
5300 S. Portland Avenue
Oklahoma City, OK 73119
Trade Name:Plasma Collection Bag
Cleared Date: 19-DEC-1986
BK870019 BioMerieux, Inc.
5300 S. Portland Avenue
Oklahoma City, OK 73119
Trade Name:Quik-Chek
Cleared Date: 19-MAY-1988
BK880003 BioMerieux, Inc.
5300 S. Portland Avenue
Oklahoma City, OK 73119
Trade Name:Therapeutic Plasmapheresis
Collection Bag
Cleared Date: 11-MAR-1988
BK920037 BioMerieux, Inc.
5300 S. Portland Avenue
Oklahoma City, OK 73119
Trade Name:PEG+
Cleared Date: 21-OCT-1993
BK960026 BioMerieux, Inc.
100 Akzo Avenue
Durham, NC 27712
Trade Name:Status Symbol TM II System
Software
Cleared Date: 16-MAR-1999
Cleared Under Organon Teknika Corporation
BK000042 BioMerieux, Inc.
100 Akzo Avenue
Durham, NC 27712
Trade Name:BacT/ALERT Culture Bottles
Cleared Date: 15-FEB-2002
BK020022 BioMerieux, Inc.
100 Rodolphe Street
Durham, NC 27712
Trade Name:BacT/ALERT SN Culture Bottle
Cleared Date: 10-OCT-2002
BK020023 BioMerieux, Inc.
100 Rodolphe Street
Durham, NC 27712
Trade Name:BacT/ALERT SA Culture Bottle
Cleared Date: 10-OCT-2002
BK020060 BioMerieux, Inc.
100 Rodolphe Street
Durham, NC 27712
Trade Name:NuclieSens HIV-1 QT RNA External
Controls
Cleared Date: 18-DEC-2002
BK030034 BioMerieux, Inc.
100 Rodolphe Street
Durham, NC 27712
Trade Name:BacT/ALERT BPN Culture Bottle
Cleared Date: 18-JUL-2003
BK030035 BioMerieux, Inc.
100 Rodolphe Street
Durham, NC 27712
Trade Name:BacT/ALERT BPA Culture Bottle
Cleared Date: 06-AUG-2003
BK030075 BioMerieux, Inc.
100 Rodolphe Street
Durham, NC 27712
Trade Name:BacT/ALERT BPN Culture Bottles
Cleared Date: 08-MAR-2004
BK030076 BioMerieux, Inc.
100 Rodolphe Street
Durham, NC 27712
Trade Name:BacT/ALERT BPA Culture Bottles
Cleared Date: 08-MAR-2004
BK050037 BioMerieux, Inc.
100 Rodolphe Street
Durham, NC 27712
Trade Name:BacT/ALERT BPA Culture Bottle
Cleared Date: 27-DEC-2005
BK050043 BioMerieux, Inc.
100 Rodolphe Street
Durham, NC 27712
Trade Name:BacT/ALERT BPN Culture Bottle
Cleared Date: 27-DEC-2005
BK040036 Biomet Biologics, Inc.
P.O. Box 587
56 East Bell Drive
Warsaw, IN 46581-0587
Trade Name:GPS II Platelet Concentrate
Separation Kit
Cleared Date: 18-JUN-2004
Cleared Under Biomet,Inc.
BK050016 Biomet Biologics, Inc.
P.O. Box 587
56 East Bell Drive
Warsaw, IN 46581-0587
Trade Name:Fibrostik Plasma Concentrator
Cleared Date: 20-JUL-2005
Cleared Under Biomet,Inc.
BK070003 Biomet Biologics, Inc.
P.O. Box 587
56 East Bell Drive
Warsaw, IN 46581-0587
Trade Name:GPS II Platelet Concentration
Separation Kit with ACD-A
Plasmax Plasma Concentrator with
GPS Mini Platelet Concentrate
Separation Kit with ACD-A
Cleared Date: 22-FEB-2007
Cleared Under Biomet,Inc.
BK070026 Biomet Biologics, Inc.
P.O. Box 587
56 East Bell Drive
Warsaw, IN 46581-0587
Trade Name:GPS III Mini Platelet Concentrate
Separation Kit with ACD-A
GPS III Platelet Concentrate
Separation Kit with ACD-A
GPS III Platelet Concentrate
Separation Kit with ACD-A Double
Kit
Cleared Date: 06-JUN-2007
Cleared Under Biomet,Inc.
BK070036 Biomet Biologics, Inc.
P.O. Box 587
56 East Bell Drive
Warsaw, IN 46581-0587
Trade Name:Vortech Concentration System
Cleared Date: 21-NOV-2007
BK970015 Biometric Imaging, Inc.
1025 Terra Bella Avenue
Mountain View, CA 94043
Trade Name:CEQer RBC Assay
Cleared Date: 18-SEP-1998
BK970016 Biometric Imaging, Inc.
1025 Terra Bella Avenue
Mountain View, CA 94043
Trade Name:CEQer PRP Assay
Cleared Date: 18-SEP-1998
BK970018 Biometric Imaging, Inc.
1025 Terra Bella Avenue
Mountain View, CA 94043
Trade Name:STELLer CD34 Assay
Cleared Date: 18-AUG-1998
BK980035 Biopool International, Inc.
1230 Wilson Drive
West Chester, PA 19380-4254
Trade Name:SliDe Chek
Cleared Date: 11-JUN-1999
BK840028 Biotech Research Laboratories, Inc.
1600 East Gude Drive
Rockville, MD 20850
Trade Name:Run Control for HBsAg Assay
Cleared Date: 25-JAN-1985
BK060066 Biotest AG
Postfach 10 20 40
D-63266 Dreiech, Germany
Trade Name:TANGO Automated Blood Bank
Analyzer System, Version 3.0
Service Pack 4
Cleared Date: 17-JAN-2007
BK950015 Biotest Diagnostics Corporation
66 Ford Road, Suite 131
Denville, NJ 07834
Trade Name:Biotest DRB-SSO Typing Kit
Cleared Date: 09-JUN-1995
BK960061 Biotest Diagnostics Corporation
66 Ford Road, Suite 131
Denville, NJ 07834
Trade Name:Biotest DQB-ELPHA
Cleared Date: 04-AUG-1997
BK960086 Biotest Diagnostics Corporation
66 Ford Road, Suite 131
Denville, NJ 07834
Trade Name:Biotest High Resolution
Supplementary Kit
Cleared Date: 03-JUL-1997
BK980007 Biotest Diagnostics Corporation
66 Ford Road, Suite 131
Denville, NJ 07834
Trade Name:BIOTEST DRB-ELPHA Low Resolution
(Enzyme Linked Probe Hybridization
Assay)
Cleared Date: 26-JAN-1999
BK980033 Biotest Diagnostics Corporation
66 Ford Road, Suite 131
Denville, NJ 07834
Trade Name:LYMPHOSCREEN ABC 60
Cleared Date: 15-DEC-1999
BK980044 Biotest Diagnostics Corporation
66 Ford Road, Suite 131
Denville, NJ 07834
Trade Name:Lymphoscreen DR 30 x 2
Cleared Date: 15-DEC-1999
BK020004 Biotest Diagnostics Corporation
66 Ford Road, Suite 131
Denville, NJ 07834
Trade Name:Biotest HLA SSP Kit
Cleared Date: 07-AUG-2002
BK080012 Biotest Medical Diagnostics GmbH
P.O. Box 10 21 50
63267 Dreiech, Germany
Trade Name:(1) Seraclone Control ABO+Rh
(2) Coombscell-E
(3) MLB2
Cleared Date: 23-JUL-2008
BK080013 Biotest Medical Diagnostics GmbH
P.O. Box 10 21 50
63267 Dreiech, Germany
Trade Name:Alsevers Solution (510(k) exempt
but part of system)
Solidscreen II Control B
Solidscreen Negative Control
Tango Optimo Automated Blood Bank
Analyzer System with version 3.1
Cleared Date: 23-JUL-2008
BK820009 Biotest-Serum-Institut GmbH
Flughafenstrasse 4
6000 Frankfurt/Main 73, Germany
Trade Name:Anti-HLA Leukocyte Typing Serum
Cleared Date: 20-JAN-1983
BK820011 Biotest-Serum-Institut GmbH
Flughafenstrasse 4
6000 Frankfurt/Main 73, Germany
Trade Name:Microdroplet Testing Tray
(Lymphotype ABC-72 Well)
Cleared Date: 20-JAN-1983
BK830027 Biotest-Serum-Institut GmbH
Flughafenstrasse 4
6000 Frankfurt/Main 73, Germany
Trade Name:Microtest Testing Tray (HLA-DR
Wells)
Cleared Date: 26-APR-1984
BK890015 Blackhawk BioSystems,Inc.
12945 Alcosta Blvd.
San Ramon, CA 94583
Trade Name:Blood Screening/Diagnostic Serum
Controls
Cleared Date: 17-APR-1992
BK890019 Blackhawk BioSystems,Inc.
12945 Alcosta Blvd.
San Ramon, CA 94583
Trade Name:Blood Bank Saline
Cleared Date: 18-JUL-1990
BK920008 Blackhawk BioSystems,Inc.
12945 Alcosta Blvd.
San Ramon, CA 94583
Trade Name:VIROTROL
Cleared Date: 17-SEP-1992
BK920028 Blackhawk BioSystems,Inc.
12945 Alcosta Blvd.
San Ramon, CA 94583
Trade Name:Virotrol HIV-2
Cleared Date: 03-JUN-1993
BK930016 Blackhawk BioSystems,Inc.
12945 Alcosta Blvd.
San Ramon, CA 94583
Trade Name:Virotrol I Reagents (CMV)
Cleared Date: 16-NOV-1993
BK930033 Blackhawk BioSystems,Inc.
12945 Alcosta Blvd.
San Ramon, CA 94583
Trade Name:Virotrol HIV-Ag
Cleared Date: 27-SEP-1995
BK930034 Blackhawk BioSystems,Inc.
12945 Alcosta Blvd.
San Ramon, CA 94583
Trade Name:Virotrol III
Cleared Date: 27-JUL-1994
BK950011 Blackhawk BioSystems,Inc.
12945 Alcosta Blvd.
San Ramon, CA 94583
Trade Name:Viroclear
Cleared Date: 28-AUG-1995
BK960085 Blackhawk BioSystems,Inc.
12945 Alcosta Blvd.
San Ramon, CA 94583
Trade Name:VIROTROL II
Cleared Date: 03-OCT-1997
BK000041 Blackhawk BioSystems,Inc.
12945 Alcosta Blvd.
San Ramon, CA 94583
Trade Name:Viroclear
Cleared Date: 28-DEC-2000
BK060052 Blackhawk BioSystems,Inc.
12945 Alcosta Blvd.
San Ramon, CA 94583
Trade Name:AmpliTrol III
Cleared Date: 07-NOV-2006
BK960044 Blood Bank Computer Systems, Inc.
1501 West Valley Highway, North
Suite 101
Auburn, WA 98001
Trade Name:Blood Bank Control System
Cleared Date: 15-OCT-1997
BK040056 Blood Bank Computer Systems, Inc.
1002 15th St. SW, Suite 120
Auburn, WA 98001-6502
Trade Name:Blood Bank Control System (BBCS) -
5.0
Cleared Date: 22-OCT-2004
BK040087 Blood Bank Computer Systems, Inc.
1002 15th St. SW, Suite 120
Auburn, WA 98001-6502
Trade Name:BBCS Lab Interface Application
(BBCS Lab) - 5.0L
Cleared Date: 15-FEB-2005
BK050013 Blood Bank Computer Systems, Inc.
1002 15th St. SW, Suite 120
Auburn, WA 98001-6502
Trade Name:BBCS Mobile Application - 5.0M
Cleared Date: 01-JUN-2005
BK940048 BloodCare
9000 Harry Hines Blvd.
Dallas, TX 75235
Trade Name:LifeTrak /Lab (a.k.a. Lab*Care) -
V. 2.01
Cleared Date: 01-OCT-1998
BK940025 Boston Scientific, Inc.
1 Boston Scientific Place
Natick, MA 01760-1537
Trade Name:Katzen Thrombolysis Guideware
Cleared Date: 24-JAN-1996
BK890009 C-six Diagnostics, Inc.
9653 N. Granville Rd.
Meguon, WI 53092
Trade Name:Frozen Cell Panel Tray (Human)
Cleared Date: 02-AUG-1989
BK890010 C-six Diagnostics, Inc.
9653 N. Granville Rd.
Meguon, WI 53092
Trade Name:Leukocyte Typing Serum Trays
(Human)
Cleared Date: 02-AUG-1989
BK890011 C-six Diagnostics, Inc.
9653 N. Granville Rd.
Meguon, WI 53092
Trade Name:Leukocyte Typing Serum Trays
(Human)
Cleared Date: 02-AUG-1989
BK960049 CIS-US, Inc.
10 de Angelo Drive
Bedford, MA 01730
Trade Name:DoseWriter
Cleared Date: 25-MAR-1998
BK950024 COBE Cardiovascular, Inc.
1201 Oak Street
Lakewood, CO 80215
Trade Name:COBE Platelet Filtration and
Storage Set
Cleared Date: 29-NOV-1995
Cleared Under COBE BCT
BK950056 COBE Cardiovascular, Inc.
1201 Oak Street
Lakewood, CO 80215
Trade Name:Cobe Spectra LRD Leukoreduction
(System Versions)
Cleared Date: 31-JAN-1996
Cleared Under COBE BCT
BK950065 COBE Cardiovascular, Inc.
1201 Oak Street
Lakewood, CO 80215
Trade Name:Cobe Spectrum Apheresis System
(stem cell collection)
Cleared Date: 28-OCT-1998
Cleared Under COBE BCT
BK960076 COBE Cardiovascular, Inc.
1201 Oak Street
Lakewood, CO 80215
Trade Name:COBE Spectra LRS Turbo System
Cleared Date: 14-JUL-1997
Cleared Under COBE BCT
BK970005 COBE Cardiovascular, Inc.
1201 Oak Street
Lakewood, CO 80215
Trade Name:Focussed System
Cleared Date: 13-OCT-1998
Cleared Under COBE BCT
BK970023 COBE Cardiovascular, Inc.
1201 Oak Street
Lakewood, CO 80215
Trade Name:Collection of pRBC Using the
Focussed System
Cleared Date: 13-OCT-1998
Cleared Under COBE BCT
BK980004 COBE Cardiovascular, Inc.
1201 Oak Street
Lakewood, CO 80215
Trade Name:COBE Spectra Apheresis System
Anticoagulant Free Flow
Restriction
Cleared Date: 09-JUL-1998
Cleared Under COBE BCT
BK990025 COBE Cardiovascular, Inc.
1201 Oak Street
Lakewood, CO 80215
Trade Name:Cobe Trima
Cleared Date: 07-APR-2000
Cleared Under COBE BCT
BK990040 COBE Cardiovascular, Inc.
1201 Oak Street
Lakewood, CO 80215
Trade Name:COBE Trima with the r/LS RBC
Leukoreduction Filter
Cleared Date: 03-MAR-2000
Cleared Under COBE BCT
BK050033 COBE Cardiovascular, Inc.
14401 West 65th Way
Arvada, CO 80004-3599
Trade Name:COBE Angel Whole Blood Separation
System
Cleared Date: 22-AUG-2005
Cleared Under COBE BCT
BK060010 COBE Cardiovascular, Inc.
14401 West 65th Way
Arvada, CO 80004-3599
Trade Name:COBE Angel Whole Blood Separation
System
Cleared Date: 27-FEB-2006
BK040002 Care Fusion, Inc.
1430 Spring Hill Road, Suite 510
McLean, VA 22102
Trade Name:wBlood Care - 1.0
Cleared Date: 10-NOV-2004
BK080035 CaridianBCT
10811 W. Collins Avenue
Lakewood, CO 80215-4498
Trade Name:COBE Spectra Apheresis System
Trima Accel Automated Blood
Component Collection System
Cleared Date: 29-AUG-2008
BK990015 Carter BloodCare
2205 Highway 121
Bedford, TX 76021
Trade Name:LifeTrak/Distribution - 2.03
Cleared Date: 22-OCT-1999
BK990027 Carter BloodCare
2205 Highway 121
Bedford, TX 76021
Trade Name:LifeTrak/Donor - 2.03
Cleared Date: 15-DEC-1999
BK020051 Cascade Medical Enterprises, LLC
20 Greenup Court
Wayne, NJ 07470
Trade Name:Cascade Medical Fibrinet,
Autologous Platelet System
Cleared Date: 20-DEC-2002
BK060006 Cascade Medical Enterprises, LLC
20 Greenup Court
Wayne, NJ 07470
Trade Name:Cascade Medical FIBRINET System
Cleared Date: 16-FEB-2006
BK030033 Celera Diagnostics, LLC
1401 Harbor Bay Parkway
Alameda, CA 94502
Trade Name:ViroSeq HIV-1 Genotyping System
Cleared Date: 11-JUN-2003
BK030088 Celera Diagnostics, LLC
1401 Harbor Bay Parkway
Alameda, CA 94502
Trade Name:ViroSeq HIV-1 Genotyping System
v2.0
Cleared Date: 22-JAN-2004
BK060049 Celera Diagnostics, LLC
1401 Harbor Bay Parkway
Alameda, CA 94502
Trade Name:ViroSeq HIV-1 Genotyping System
Cleared Date: 31-AUG-2006
BK080026 Celera Diagnostics, LLC
1401 Harbor Bay Parkway
Alameda, CA 94502
Trade Name:ViroSeq HIV-1 Genotyping System
v2.0
Cleared Date: 10-JUL-2008
BK880002 Cellular Products
688 Main Street
Buffalo, NY 14202
Trade Name:Blood Bank Refrigerator
Cleared Date: 04-MAY-1988
BK950010 Centocor, Inc.
200 Great Valley Parkway
Malvern, PA 19355
Trade Name:CAPTIA CMV-TA EIA
Cleared Date: 22-MAR-1995
BK950051 Cerner Corporation
2800 Rock Creek Parkway
Kansas City, MO 64117-2551
Trade Name:Pathnet Blood Center (L-2510)
Cleared Date: 16-JUL-1997
BK950053 Cerner Corporation
2800 Rock Creek Parkway
Kansas City, MO 64117-2551
Trade Name:Pathnet Blood Bank Transfusion (L-
2300)
Cleared Date: 16-JUL-1997
BK950055 Cerner Corporation
2800 Rock Creek Parkway
Kansas City, MO 64117-2551
Trade Name:Pathnet Blood Bank Donor (L2400)
Cleared Date: 16-JUL-1997
BK960024 Cerner Corporation
2800 Rock Creek Parkway
Kansas City, MO 64117-2551
Trade Name:PathNet Worksystem Blood Bank
Transfusion (L2812)
Cleared Date: 16-JUL-1997
BK990007 Cerner Corporation
2800 Rock Creek Parkway
Kansas City, MO 64117-2551
Trade Name:HNA Millennium PathNet Blood Bank
Transfusion
Cleared Date: 02-NOV-1999
BK030028 Cerner Corporation
2800 Rock Creek Parkway
Kansas City, MO 64117-2551
Trade Name:Cerner Millennium PathNet Blood
Bank Donor (PA-22200) - 2003.01
Cleared Date: 19-AUG-2003
BK060037 Cerner Corporation
2800 Rock Creek Parkway
Kansas City, MO 64117-2551
Trade Name:Cerner Bridge Medical Transfusion
Administration and Specimen
Collections - 3.3
Cleared Date: 24-MAY-2007
BK860025 Cetus Corporation
1400 53rd Street
Emeryville, CA 94608
Trade Name:Pro Group System
Cleared Date: 27-APR-1987
BK050021 Charter Medical, Ltd.
3948-A Westpoint Blvd.
Winston-Salem, NC 27103
Trade Name:Charter Medical Transfer Set
Cleared Date: 22-JUL-2005
BK910003 CharterMed, Inc.
3948-A West Point Blvd.
Winston-Salem, NC 27103
Trade Name:CharterMed Blood Freezing Bag
Cleared Date: 11-MAR-1993
BK960043 CharterMed, Inc.
3948-A West Point Blvd.
Winston-Salem, NC 27103
Trade Name:Charter Med Transfer Bags
Cleared Date: 11-SEP-1996
BK000049 Chiron Corporation
4560 Horton Street
Emeryville, CA 94608-2916
Trade Name:Chiron CPT Pooling Software,
Version 2.0.0.2
Cleared Date: 04-DEC-2001
BK010025 Chiron Corporation
4560 Horton Street
Emeryville, CA 94608-2916
Trade Name:Chiron Procleix NAT Tracker - 1.0E
Cleared Date: 03-JAN-2002
Cleared Under Rubin & Poor
BK030030 Chiron Corporation
4560 Horton Street
Emeryville, CA 94608-2916
Trade Name:Procleix NAT Tracker
Cleared Date: 23-MAY-2003
Cleared Under Rubin & Poor
BK040058 Chiron Corporation
4560 Horton Street
Emeryville, CA 94608-2916
Trade Name:Chiron CPT Pooling Software,
Version 2.0.0.2
Cleared Date: 28-JUL-2004
BK040072 Chiron Corporation
4560 Horton Street
Emeryville, CA 94608-2916
Trade Name:Procleix NAT Tracker Software
Version 2.1
Cleared Date: 04-NOV-2004
BK050004 Chiron Corporation
4560 Horton Street
Emeryville, CA 94608-2916
Trade Name:Procleix Optiva RAS
Cleared Date: 08-APR-2005
BK060005 Chiron Corporation
4560 Horton Street
Emeryville, CA 94608-2916
Trade Name:Chiron Procleix NAT Tracker - 3.0
Cleared Date: 01-MAR-2006
BK070007 Chiron Corporation
4560 Horton Street
Emeryville, CA 94608-2916
Trade Name:PROCLEIX NAT TRACKER
Cleared Date: 06-MAR-2007
BK840008 Cobe Laboratories, Inc.
1185 Oak Street
Lakewood, CO 80215
Trade Name:IBM 2991 - Change of Ownership
Cleared Date: 08-JUN-1984
BK840009 Cobe Laboratories, Inc.
1185 Oak Street
Lakewood, CO 80215
Trade Name:IBM 2997 - Change of Ownership
Cleared Date: 08-JUN-1984
BK870022 Cobe Laboratories, Inc.
1185 Oak Street
Lakewood, CO 80215
Trade Name:COBE Spectra Blood Component
Separator
Cleared Date: 20-JUN-1988
BK900002 Cobe Laboratories, Inc.
1185 Oak Street
Lakewood, CO 80215
Trade Name:COBE Spectra: Simultaneous
Collection of Platlets and Plasma
Cleared Date: 21-JUN-1990
BK900003 Cobe Laboratories, Inc.
1185 Oak Street
Lakewood, CO 80215
Trade Name:COBE Spectra: Change in
Anticoagulant Ratio
Cleared Date: 14-NOV-1990
BK900004 Cobe Laboratories, Inc.
1185 Oak Street
Lakewood, CO 80215
Trade Name:COBE Spectra: Single Needle
System
Cleared Date: 21-JUN-1990
BK910020 Cobe Laboratories, Inc.
1185 Oak Street
Lakewood, CO 80215
Trade Name:COBE SPECTRATHERM
Cleared Date: 02-NOV-1992
BK920011 Cobe Laboratories, Inc.
1185 Oak Street
Lakewood, CO 80215
Trade Name:Cobe Spectra with PCM
Cleared Date: 15-MAY-1995
BK920036 Cobe Laboratories, Inc.
1185 Oak Street
Lakewood, CO 80215
Trade Name:COBE Spectra Single-Needle
Extended Life Platelet (ELP) Set
Cleared Date: 06-APR-1993
BK930017 Cobe Laboratories, Inc.
1185 Oak Street
Lakewood, CO 80215
Trade Name:COBE Spectra Apheresis System
(Triple Platelet)
Cleared Date: 27-JUL-1994
BK940016 Cobe Laboratories, Inc.
1185 Oak Street
Lakewood, CO 80215
Trade Name:COBE Spectra Version 4
Cleared Date: 20-SEP-1994
BK950030 Cobe Laboratories, Inc.
1185 Oak Street
Lakewood, CO 80215
Trade Name:COBE Spectra Extended Life
Platelet Set
Cleared Date: 15-FEB-1996
BK970007 Community Bio-Resources, Inc.
2197 Parkway Lake Drive
Hoover, AL 35244
Trade Name:Donor Information System - 1.0
Cleared Date: 09-APR-1997
BK960060 Community Blood Center of Greater Kansas
City
4040 Main Street
Kansas City, MO 64111
Trade Name:CBC Blood System, Version 1.2
Cleared Date: 20-NOV-1997
BK920006 Connaught Laboratories Limited
1755 Steeles Avenue West
Willowdale, Canada
Trade Name:CONTINENTAL REFRIG. BLD.BNK. MODEL
C-BBRA-1S
Cleared Date: 17-JUL-1992
BK970010 Controlled Chemicals, Inc.
317 S. Division
Suite 9
Ann Arbor, MI 48104
Trade Name:CryoGuard Thermal Exposure
Indicator
Cleared Date: 26-AUG-1997
BK940026 Cook, Inc.
925 S. Curry Pike
Bloomington, IN 47402
Trade Name:Roubin Infusion Catheter
Cleared Date: 29-JUN-1995
BK830008 Cooper Biomedical
1230 Wilson Drive
West Chester, PA 19380
Trade Name:W.A.R.M.
Cleared Date: 21-JUN-1983
BK850008 Cooper Biomedical
1 Technology Court
Malvern, PA 29355
Trade Name:H.P.C.
Cleared Date: 09-JAN-1986
BK850009 Cordis Laboratories, Inc.
2140 North Miami Avenue
Miami, FL 33127
Trade Name:CORDIA HTLV-I
Cleared Date: 03-OCT-1985
BK820007 Cry-O-Safe, Inc.
999 Airport Road
Lakewood, NJ 08701
Trade Name:Plasma Safe
Cleared Date: 26-JUL-1982
BK820018 Cryosan Inc.
850 Providence Highway
Dedham, MA 02026
Trade Name:Dideco BT Series
Cleared Date: 16-DEC-1982
BK820021 Cryosan Inc.
850 Providence Highway
Dedham, MA 02026
Trade Name:Dideco BT790/A
Dideco BT792
Cleared Date: 03-JAN-1983
BK830015 Cryosan Inc.
850 Providence Highway
Dedham, MA 02026
Trade Name:Dideco BT 125
Dideco BT 225
Dideco BT 375
Dideco BT 691
Cleared Date: 31-OCT-1983
BK830016 Cryosan Inc.
850 Providence Highway
Dedham, MA 02026
Trade Name:Dideco Progress BT 790/A
Cleared Date: 07-FEB-1984
BK840011 Cryosan Inc.
850 Providence Highway
Dedham, MA 02026
Trade Name:BT 765 Blood Cell Separator
Equipment
Cleared Date: 10-APR-1985
BK840012 Cryosan Inc.
850 Providence Highway
Dedham, MA 02026
Trade Name:BT 765 Elutriation Pump
Cleared Date: 06-FEB-1985
BK850003 Cryosan Inc.
850 Providence Highway
Dedham, MA 02026
Trade Name:Cryosan Pediatric Pack
Cleared Date: 05-APR-1985
BK870003 Cryosan Inc.
850 Providence Highway
Dedham, MA 02026
Trade Name:Cryo-PakTM System
Cleared Date: 17-APR-1987
BK820014 Cutter Biological
4th&Paker St,
Berkley, CA 94701
Trade Name:Plasma Pooling Bags
Cleared Date: 08-FEB-1983
BK840010 Cutter Biological
4th&Paker St,
Berkley, CA 94701
Trade Name:CLX Transfer Bag
Cleared Date: 15-AUG-1984
BK860001 Cutter Biological
4th&Paker St,
Berkley, CA 94701
Trade Name:Leukotrap System
Cleared Date: 05-AUG-1986
BK860040 Cutter Biological
4th&Paker St,
Berkley, CA 94701
Trade Name:Blood Collection Unit w/o
Anticoagulant
Cleared Date: 24-JUN-1987
BK960012 CytoTherm LP
110 Sewell Avenue
Trenton, NJ 08610
Trade Name:Cyto Therm (T-S)
Cleared Date: 15-APR-1996
Cleared Under Photo-Therm
BK980042 CytoTherm LP
110 Sewell Avenue
Trenton, NJ 08610
Trade Name:CytoTherm J
Cleared Date: 07-JAN-1999
Cleared Under Photo-Therm
BK060027 CytoTherm LP
110 Sewell Avenue
Trenton, NJ 08610
Trade Name:CytoTherm Plasma Thawing System
Cleared Date: 01-AUG-2006
BK060063 CytoTherm LP
110 Sewell Avenue
Trenton, NJ 08610
Trade Name:CytoTherm Cryoprecipitate Thawer,
Model CT-4T.6C
Cleared Date: 04-MAY-2007
BK080019 CytoTherm LP
110 Sewell Avenue
Trenton, NJ 08610
Trade Name:CytoTherm Plasma Thawing System
Cleared Date: 16-JUL-2008
BK950060 Cytosol Laboratories, Inc.
55 Messina Drive
Braintree, MA 02184-6783
Trade Name:Y-Type Rejuvenation Set PN7212
Cleared Date: 25-NOV-1996
BK000022 DENCO, INC.
P.O.BOX 9600
Wilmington, DE 19809
Trade Name:Total Containment Device
Cleared Date: 18-APR-2000
BK990041 DENCO, INC.
P.O.BOX 9600
Wilmington, DE 19809
Trade Name:Total Containment Device
Cleared Date: 21-DEC-1999
BK950019 DUPACO
2620 TEMPLE HEIGHTS DR.
OCEANSIDE, CA 92056
Trade Name:DUPACO BLOOD/FLUID WARMING SET
D25416
Cleared Date: 27-APR-1995
BK950038 DUPACO
2620 TEMPLE HEIGHTS DR.
OCEANSIDE, CA 92056
Trade Name:Dupaco Counterflo 300 Blood/Fluid
Warmer
Cleared Date: 01-SEP-1995
BK020057 Data Innovations Inc.
120 Kimball Ave., Suite 100
South Burlington, VT 05430
Trade Name:imExpress - 7.2.5
Cleared Date: 29-JUL-2003
Cleared Under Data Innovations
BK060053 Data Innovations Inc.
120 Kimball Ave., Suite 100
South Burlington, VT 05430
Trade Name:Instrument Manager - 8.05.01.10
Cleared Date: 05-JAN-2007
BK960004 Defense Blood Standard System
5205 Leesburg Pike
Suite 1000
Falls Church, VA 22041
Trade Name:Defense Blood Standard System
(DBSS) (Version 1.0/1.03)
Cleared Date: 01-AUG-1997
Cleared Under Department of Defense
BK980031 Defense Blood Standard System
5205 Leesburg Pike
Suite 1000
Falls Church, VA 22041
Trade Name:DBSS - 3.00
Cleared Date: 31-AUG-1998
Cleared Under Department of Defense
BK070035 Defense Blood Standard System
5205 Leesburg Pike
Suite 1000
Falls Church, VA 22041
Trade Name:Defense Blood Standard System
(DBSS) - 10.0.0
Cleared Date: 22-MAY-2008
BK970021 Department of Veterans Affairs
P.O. Box 5000
VA Hines Medical Center
Hines, IL 60141
Trade Name:Vista Blood Bank Software (V5.2)
Cleared Date: 23-APR-1999
BK060043 Department of Veterans Affairs
P.O. Box 7008
Hines, IL 60141-7008
Trade Name:VistA Blood Establishment Computer
Software (VBECS) - 1.0
Cleared Date: 19-OCT-2006
BK830025 Dia Tech
2525 Shader Road
Orlando, FL 328
Trade Name:DiaCent 2 Automated Cell
Washer/Centrifuge
Cleared Date: 10-JAN-1984
BK840001 Dia Tech
2525 Shader Road
Orlando, FL 328
Trade Name:DIACENT 1, Automated Cell
Washer/Centrifuge
Cleared Date: 19-MAR-1984
BK870007 DiaClin Laboratories, Inc.
450 10th Circle North
Nashville, TN 37203
Trade Name:SEOPF ROP Tray
Cleared Date: 04-APR-1990
BK970013 Digi-Trax Corporation
1550 Barclay Boulevard
Buffalo Grove, IL 60089
Trade Name:Donor-ID
Cleared Date: 27-FEB-1998
BK000020 Digi-Trax Corporation
1550 Barclay Boulevard
Buffalo Grove, IL 60089
Trade Name:Digi-Trax Donor-ID - 2.0
Cleared Date: 20-APR-2000
BK010049 Digi-Trax Corporation
1550 Barclay Boulevard
Buffalo Grove, IL 60089
Trade Name:Donor-ID - 2.2
Cleared Date: 26-APR-2002
BK850006 Division of Immunologic Oncology
3900 Reservoir Rd.,NW,Box 63,Med-Den
Bld
Washington, DC 20007
Trade Name:GTU DR/DQ Typing Tray
Cleared Date: 25-APR-1985
BK980009 Dominion Biologicals Limited
5 Isnor Drive
Dartmouth, Nova Scotia Canada B3B1M1
Trade Name:Coombs Control Cells (IgG Coated)
Cleared Date: 30-OCT-1998
BK070065 Duley Hopkins and Associates
1200 Mountain Creek Road
# 215
Chattanooga, TN 37405
Trade Name:Blood Bank Information Management
System (BBIMS) - V2.05.01
Cleared Date: 25-APR-2008
BK030056 Dynal Biotech Ltd
11 Bassendale Road
Croft Busines Park
Bromborough, Wirral, CH62 3QL, United
Kingdom
Trade Name:Dynal Reli SSO HLA-A Typing Kit
Cleared Date: 29-JAN-2004
BK030057 Dynal Biotech Ltd
11 Bassendale Road
Croft Busines Park
Bromborough, Wirral, CH62 3QL, United
Kingdom
Trade Name:Dynal Reli SSO HLA-B Typing Kit
Cleared Date: 29-JAN-2004
BK030058 Dynal Biotech Ltd
11 Bassendale Road
Croft Busines Park
Bromborough, Wirral, CH62 3QL, United
Kingdom
Trade Name:DYNAL RELI SSO HLA-Cw Typing Kit
Cleared Date: 29-JAN-2004
BK030059 Dynal Biotech Ltd
11 Bassendale Road
Croft Busines Park
Bromborough, Wirral, CH62 3QL, United
Kingdom
Trade Name:Dynal RELI SSO HLA-DQB1 Typing Kit
Cleared Date: 29-JAN-2004
BK030060 Dynal Biotech Ltd
11 Bassendale Road
Croft Busines Park
Bromborough, Wirral, CH62 3QL, United
Kingdom
Trade Name:DYNAL RELI SSO HLA-DRB Typing
System.
Cleared Date: 29-JAN-2004
BK050012 Dynal Biotech Ltd
11 Bassendale Road
Croft Busines Park
Bromborough, Wirral, CH62 3QL, United
Kingdom
Trade Name:Dynal RELI SSO HLA-DRB1 Typing Kit
-
For Use as a manual asssay or with
the AutoRELI Instrument
Cleared Date: 18-MAY-2005
BK960041 Dynamic Healthcare Technologies, Inc.
101 Southhall Lane, Suite 210
Maitland, FL 32751
Trade Name:Transfusion Service Mgr.
Cleared Date: 16-DEC-1997
BK840004 Dynatech Laboratories, Inc.
900 Slaters Lane
Alexandria, VA 22314
Trade Name:MicroBBank 220 Automated
Microplate Reader
Cleared Date: 18-MAY-1984
BK850013 Dynatech Laboratories, Inc.
900 Slaters Lane
Alexandria, VA 22314
Trade Name:MicroBank System
Cleared Date: 08-OCT-1985
BK840003 E.I. duPont de Nemours & Company
Medical Products Department
Wilmington, DE 19898
Trade Name:DuPont SCD
Cleared Date: 07-NOV-1984
BK910022 E.I. duPont de Nemours & Company
Medical Products Department
Wilmington, DE 19898
Trade Name:Du Pont Sorvall RC 3B Plus
Du Pont Sorvall RC 3C Plus
Centrifuge
Cleared Date: 21-JAN-1992
BK840018 EK Industries, Inc.
411 Kay Avenue
Addison, IL 60101
Trade Name:Copper Sulfate Solution ( for
women)
Cleared Date: 11-DEC-1984
BK840019 EK Industries, Inc.
411 Kay Avenue
Addison, IL 60101
Trade Name:Copper Sulfate Solution (for men)
Cleared Date: 11-DEC-1984
BK900006 Electrolux SARL
1317 F St. NW, suite 150
Washington, DC 20004
Trade Name:Blood Chain Thermostabilizer
RCB42P
Cleared Date: 18-JUL-1990
BK860018 Engineering & Research Associates, Inc.
500 North Tucson Boulevard (ERA
Plaza)
Tucson, AZ 85716
Trade Name:SEBRA Model 1150 (Blood Weigth
Monitor)
Cleared Date: 11-JUL-1986
BK860019 Engineering & Research Associates, Inc.
500 North Tucson Boulevard (ERA
Plaza)
Tucson, AZ 85716
Trade Name:SEBRA Model 1300 (Tube Stripper)
Cleared Date: 29-SEP-1986
BK870023 Engineering & Research Associates, Inc.
500 North Tucson Boulevard (ERA
Plaza)
Tucson, AZ 85716
Trade Name:Sebra Model #1500 Centrifuge Cup
Blood Bag Holder
Cleared Date: 25-SEP-1986
BK900025 Engineering & Research Associates, Inc.
500 North Tucson Boulevard (ERA
Plaza)
Tucson, AZ 85716
Trade Name:SEBRA Model #2470, Mobile Tube
Sealer
Cleared Date: 26-JUN-1991
BK900026 Engineering & Research Associates, Inc.
500 North Tucson Boulevard (ERA
Plaza)
Tucson, AZ 85716
Trade Name:SEBRA MODEL #1040, DIGITAL BLOOD
SHAKER/WEIGHT MONITOR
Cleared Date: 26-JUN-1991
BK900029 Engineering & Research Associates, Inc.
500 North Tucson Boulevard (ERA
Plaza)
Tucson, AZ 85716
Trade Name:Sebra Model #2390, Mobile Tube
Sealer
Cleared Date: 26-JUN-1991
BK910015 Engineering & Research Associates, Inc.
500 North Tucson Boulevard (ERA
Plaza)
Tucson, AZ 85716
Trade Name:Sebra Model #1290, Blood/Platelet
Coolant
Cleared Date: 11-SEP-1991
BK920002 Ethox Corp.
251 Seneca St,
Buffalo, NY 14204
Trade Name:Ethox Transfer Pack
Cleared Date: 17-SEP-1992
BK920026 Fenwal Blood Technologies
25212 W. Illinois Route 120, RLP-34
Round Lake, Il 60073
Round Lake, IL 60073
Trade Name:SDP Microplate Assay Management
Software
Cleared Date: 30-JUL-1993
Cleared Under Genetic Systems Corporation
BK080018 Fenwal Blood Technologies
Three Corporate Drive
Lake Zurich, IL 60047
Trade Name:Amicus Separator System
Cleared Date: 26-AUG-2008
BK080033 Fenwal Blood Technologies
Three Corporate Drive
Lake Zurich, IL 60047
Trade Name:PLASMALINK
Cleared Date: 22-AUG-2008
BK830010 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:Transfer Pack Unit(s) with
Sterile Connector
Cleared Date: 23-AUG-1988
Cleared Under Travenol Laboratories
BK830011 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:Closed Apheresis Kit for Extended
Platelet Storage
Cleared Date: 27-MAY-1983
Cleared Under Travenol Laboratories
BK830009 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:Plasma-Gard
Cleared Date: 25-JAN-1984
Cleared Under Travenol Laboratories
BK860015 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:Apheresis Kit/Extended Plate.
Stor. & Plas. Coll.
Cleared Date: 03-JUL-1986
Cleared Under Travenol Laboratories
BK860029 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:Isoradial Separation Chamber
Cleared Date: 28-NOV-1986
Cleared Under Travenol Laboratories
BK860035 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:CS-3000 Bld Cell Separator Bld
Sample Containers
Cleared Date: 26-FEB-1987
Cleared Under Travenol Laboratories
BK870017 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:Fenwal LS-300 Centrifuge
Cleared Date: 16-NOV-1987
Cleared Under Fenwal Laboratories
BK880023 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:Fenual CS3000 Blood Cell Separator
Cleared Date: 13-JUN-1989
Cleared Under Travenol Laboratories
BK900005 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:Closed System Apheresis Kit-
CS3000 Blood Cell Separator
Cleared Date: 05-JUN-1990
Cleared Under Baxter Healthcare
Corporation
BK900016 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:Closed System Apheresis Kit CS-
3000 Blood Cell Separator (single
venous access for platelet
collection)
Cleared Date: 07-JUN-1991
Cleared Under Baxter Healthcare
Corporation
BK900020 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:Optum Platelet Separation Chamber
Cleared Date: 07-NOV-1990
Cleared Under Baxter Healthcare
Corporation
BK910014 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:Sepacell R-200; Pre-Storage
Leukocyte Depletion Set for Red
Blood
Cleared Date: 18-SEP-1991
Cleared Under Baxter Healthcare
Corporation
BK910032 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:OptiPress
Cleared Date: 03-JUN-1993
Cleared Under Baxter Healthcare
Corporation
BK920003 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:Fenwal Needle/Tube Sampling
Protector/Safety Cover
Cleared Date: 12-MAR-1992
Cleared Under Baxter Healthcare
Corporation
BK920029 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:30-mL Collection Chamber for CS-
3000 Plus Blood Cell Separator
Cleared Date: 06-MAY-1994
Cleared Under Baxter Healthcare
Corporation
BK920032 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:Sepacell Pre-storage Leukocyte
Depletion Set for Red Cell
Cleared Date: 07-JUN-1993
Cleared Under Baxter Healthcare
Corporation
BK920038 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:Closed System Apheresis Kit with
Integral Leukocyte Removal Filter
Cleared Date: 27-JUL-1994
Cleared Under Baxter Healthcare
Corporation
BK930029 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:AccessTM Management System (AMS)
Cleared Date: 20-JUN-1994
Cleared Under Baxter Healthcare
Corporation
BK940005 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:Fenwal Bone Marrow Collection Kit
w/ Flexible Pre-filter and Inline
Filters and Fenwal Bone Marrow
Collection Stand
Cleared Date: 18-MAY-1994
Cleared Under Baxter Healthcare
Corporation
BK940009 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:Optipress TM Automated Blood
Component
Cleared Date: 18-MAY-1994
Cleared Under Baxter Healthcare
Corporation
BK940013 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:Ex Storage PL 732 Containers w/
Sepacell Filter for Leukocytes
Reduced Platelets
Cleared Date: 27-JUL-1994
Cleared Under Baxter Healthcare
Corporation
BK940023 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:Accessory Weight Scale for Medical
Purposes
Cleared Date: 05-JUL-1994
Cleared Under Baxter Healthcare
Corporation
BK940036 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:Storage Containers for CS-3000
Apheresis Kit
Cleared Date: 27-DEC-1994
Cleared Under Baxter Healthcare
Corporation
BK940040 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:Sepacell PLS-10A,5A Leukocyte
Reduction Filter Platelet Products
Cleared Date: 28-FEB-1995
Cleared Under Baxter Healthcare
Corporation
BK940041 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:Sepacell R-2000 Prestorage
Leukocyte Reduction Set for Red
Blood Cells
Cleared Date: 14-FEB-1995
Cleared Under Baxter Healthcare
Corporation
BK950013 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:CS-3000 Plus (mononeuclear cells)
Cleared Date: 28-OCT-1998
Cleared Under Baxter Healthcare
Corporation
BK950016 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:Pall BPF4 Leukocyte Reduction Set
for RBC
Cleared Date: 20-SEP-1995
Cleared Under Baxter Healthcare
Corporation
BK950023 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:CS-3000 Blood Cell Separator
Apheresis Kit
Cleared Date: 29-JUN-1995
Cleared Under Baxter Healthcare
Corporation
BK960005 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:Amicus Separator
Cleared Date: 19-DEC-1996
Cleared Under Baxter Healthcare
Corporation
BK960083 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:Hematype Segment Device
Cleared Date: 28-FEB-1997
Cleared Under Medical Safety Products,
Inc.
BK980041 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:Sepacell Pre-Storage Leukocyte
Reduction Set for Red Cells
Cleared Date: 16-JUL-1999
Cleared Under Baxter Healthcare
Corporation
BK990009 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:Fenwal Amicus Separator Collection
of Three Platelet Products
Cleared Date: 03-MAR-2000
Cleared Under Baxter Healthcare
Corporation
BK000039 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:Amicus Separator, Concurrent
Collection of Red Blood Cells
Cleared Date: 26-AUG-2002
Cleared Under Baxter Healthcare
Corporation
BK000047 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:Amicus Separator, Mononuclear Cell
Collection
Cleared Date: 31-JUL-2002
Cleared Under Baxter Healthcare
Corporation
BK010016 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:Apheresis Data Integration System
(ADIS)
Cleared Date: 04-DEC-2001
Cleared Under Baxter Healthcare
Corporation
BK010033 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:Cygnet System
Cleared Date: 27-AUG-2002
Cleared Under Baxter Healthcare
Corporation
BK020008 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:LeukoConnect - Pre-Storage Sterile
Connect Leukoreduction Set with
Sepacell Filter for Red Blood
Cells
Cleared Date: 10-DEC-2002
Cleared Under Baxter Healthcare
Corporation - I.V. Systems Division
BK020056 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:ALYX System
Cleared Date: 20-DEC-2002
Cleared Under Baxter Healthcare
Corporation
BK030085 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:ALYX Component Collection System
and Amicus Separator System
Cleared Date: 15-MAR-2004
Cleared Under Baxter Healthcare
Corporation
BK040059 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:Amicus Separator System
Cleared Date: 24-SEP-2004
Cleared Under Baxter Healthcare
Corporation - Transfusion Therapies
Division
BK040084 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:ALYX Component Collection System
Cleared Date: 15-MAR-2005
Cleared Under Baxter Healthcare
Corporation
BK050020 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:LeukoConnect - Pre-Storage Sterile
Connect Leukoreduction Set with
Sepacell Filter for Red Blood
Cells in additive solution
Cleared Date: 17-MAY-2005
Cleared Under Baxter Healthcare
Corporation
BK050038 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:AMICUS Separator System
Cleared Date: 03-NOV-2005
Cleared Under Baxter Healthcare
Corporation
BK060061 Fenwal Inc
25212 W. Illinois Route 120, RLP-34
Round Lake, IL 60073
Trade Name:ALYX Component Collection System:
ALYX 2RBC-NLR Kit
Cleared Date: 09-FEB-2007
Cleared Under Baxter Healthcare
Corporation
BK080024 Fenwal Inc
Three Corporate Drive
Lake Zurich, IL 60047
Trade Name:ALYX Component Collection System
Cleared Date: 24-JUN-2008
BK030022 Fresenius Medical Care North America
6675 185th Avenue NE
Suite 100
Redmond, WA 98052
Trade Name:Fresenius Compomat G4 &
Compomaster NT
Cleared Date: 11-JUL-2003
Cleared Under Fresenius Hemocare Inc.
BK040005 Fresenius Medical Care North America
95 Hayden Avenue
Lexington, MA 02420-9192
Trade Name:Fresenius Compoguard &
Donationmaster NT
Cleared Date: 26-MAR-2004
Cleared Under Fresenius Hemocare Inc.
BK040076 Fresenius Medical Care North America
95 Hayden Avenue
Lexington, MA 02420-9192
Trade Name:Compodock
Cleared Date: 17-DEC-2004
Cleared Under Fresenius Hemocare Inc.
BK880007 Fresenius USA/Seratronics Inc.
2637 Shadelands Drive
Walnut Creek, CA 94598
Trade Name:Fresenius AS104 Cell Separator
Cleared Date: 22-JUL-1996
BK880018 Fresenius USA/Seratronics Inc.
4090 Pike Lane
Concord, CA 94502
Trade Name:Astotherm IFT 200; IFT 220
Cleared Date: 25-AUG-1988
BK960066 Frigidaire Commercial Products Company
707 Robins St
Conway, AR 72032
Trade Name:Eagle Series Blood Storage
Refrigerator # ST30RGBB and ST50
Cleared Date: 30-AUG-1996
BK960092 Fujirebio America Inc.
30 Two Bridges Road
Suite 250
Fairfield, NJ 07004
Trade Name:Olympus PK CMV-PA System &
Controls
Cleared Date: 28-OCT-1998
BK030007 Fujirebio Diagnostics, Inc.
201 Great Valley Parkway
Malvern, PA 19355
Trade Name:Olympus PK TP System
Cleared Date: 21-FEB-2003
BK060062 Fujirebio Diagnostics, Inc.
201 Great Valley Parkway
Malvern, PA 19355
Trade Name:Olympus PK® TP Reagent System
Cleared Date: 25-JUN-2007
BK070030 Fujirebio Diagnostics, Inc.
201 Great Valley Parkway
Malvern, PA 19355
Trade Name:Olympus PK CMV-PA Test System and
Controls
Olympus PK7300 Automated Blood
Bank Analyzer
Cleared Date: 20-SEP-2007
BK940047 Fujirebio, Inc.
1129 Bloomfield Ave,
West Caldwell, NJ 07006
Trade Name:Olympus PK TP System Reactive
Control
Cleared Date: 29-NOV-1995
BK920005 Futuremed
2076 Deer Park Avenue
Deer Park, NY 11729
Trade Name:AM-4
Cleared Date: 29-SEP-1994
BK940055 Futuremed
2076 Deer Park Avenue
Deer Park, NY 11729
Trade Name:L Fusion Bags for Warming
Blood/Plasma w/ ANIMEC4
Cleared Date: 27-DEC-1994
BK050018 GE Medical Information Technologies
540 Northwest Highway
Barrington, IL 60010
Trade Name:Centricity Ultra Laboratory
Transfusion Medicine (Ultra TM) -
4.0
Cleared Date: 13-JUN-2005
BK040019 GTI, INC
20925 Crossroads Circle
Waukesha, WI 53186
Trade Name:Antibody Monitoring System Class I
and Class II (AMS1 and AMS1+2)
Cleared Date: 06-JUL-2004
BK040034 GTI, INC
20925 Crossroads Circle
Waukesha, WI 53186
Trade Name:Lifecodes LifeScreen: A Luminex
100 Screening Assay for the
Detection of IgG Antibodies to HLA
Class I and Class II Molecules of
Human Origin
Cleared Date: 16-JUL-2004
BK040035 GTI, INC
20925 Crossroads Circle
Waukesha, WI 53186
Trade Name:Lifecodes ID Class I: A Luminex
100 screening assay for the
qualitative detection of IgG panel
reactive antibodies (PRA) to HLA
Class I molecules
Lifecodes ID Class II: A Luminex
100 screening assay for the
qualitative detection of IgG panel
reactive antibodies (PRA) to HLA
Class II molecules
Cleared Date: 16-JUL-2004
BK050040 GTI, INC
20925 Crossroads Circle
Waukesha, WI 53186
Trade Name:ThromboType (HPA 1-6, 15) and
ThromboType 1 (HPA 1)
Cleared Date: 20-JAN-2006
BK050054 GTI, INC
20925 Crossroads Circle
Waukesha, WI 53186
Trade Name:GranType(TM)
Cleared Date: 02-MAR-2006
BK060038 GTI, INC
20925 Crossroads Circle
Waukesha, WI 53186
Trade Name:MICROAMS
Cleared Date: 28-JUL-2006
BK070034 GTI, INC
20925 Crossroads Circle
Waukesha, WI 53186
Trade Name:HLA EZ Type
Cleared Date: 10-JUL-2008
BK070045 GTI, INC
20925 Crossroads Circle
Waukesha, WI 53186
Trade Name:Donor Screen HLA Class I and Class
II
Cleared Date: 30-JUL-2008
BK010006 Gambro BCT, Inc
10811 W. Collins Ave.
Lakewood, CO 80215-4498
Trade Name:Trima Automated Blood Component
Collection System
Cleared Date: 27-FEB-2002
BK010037 Gambro BCT, Inc
10811 W. Collins Ave.
Lakewood, CO 80215-4498
Trade Name:Platelet collection sets for the
COBE Spectra Apheresis System and
the Trima Automated Blood
Component Collection System.
Cleared Date: 09-DEC-2002
BK010046 Gambro BCT, Inc
10811 W. Collins Ave.
Lakewood, CO 80215-4498
Trade Name:Trima Automated Blood Collection
System (Single Stage)
Cleared Date: 18-SEP-2002
BK010050 Gambro BCT, Inc
10811 W. Collins Ave.
Lakewood, CO 80215-4498
Trade Name:Trima Automated Blood Collection
System
Cleared Date: 18-SEP-2002
BK020015 Gambro BCT, Inc
10811 W. Collins Ave.
Lakewood, CO 80215-4498
Trade Name:Vista Information System,
Independent Solution
Cleared Date: 15-JUL-2002
BK020041 Gambro BCT, Inc
10811 W. Collins Ave.
Lakewood, CO 80215-4498
Trade Name:COBE Spectra Apheresis
System/Blood component disposable
collection sets for apheresis
Cleared Date: 23-APR-2003
BK030021 Gambro BCT, Inc
10811 W. Collins Ave.
Lakewood, CO 80215-4498
Trade Name:Vista Information System - 2.1
Cleared Date: 01-MAY-2003
BK030083 Gambro BCT, Inc
10811 W. Collins Ave.
Lakewood, CO 80215-4498
Trade Name:Trima Accel
Cleared Date: 14-JAN-2004
BK040069 Gambro BCT, Inc
10811 W. Collins Ave.
Lakewood, CO 80215-4498
Trade Name:Trima Automated Blood Component
Collection System - Blood
Component Sampling Accessory
Cleared Date: 28-OCT-2004
BK040086 Gambro BCT, Inc
10811 W. Collins Ave.
Lakewood, CO 80215-4498
Trade Name:COBE Spectra Apheresis System &
Trima Automated Blood Component
Collection System
Cleared Date: 15-MAR-2005
BK070001 Gambro BCT, Inc
10811 W. Collins Ave.
Lakewood, CO 80215-4498
Trade Name:Vista Information System - 3.0
Cleared Date: 27-JUN-2007
BK070066 Gambro BCT, Inc
10811 W. Collins Ave.
Lakewood, CO 80215-4498
Trade Name:Vista Information System, Version
3.0 with Medical Review Module
Cleared Date: 13-DEC-2007
BK080010 Gambro BCT, Inc
10811 W. Collins Ave.
Lakewood, CO 80215-4498
Trade Name:The Atreus Whole Blood Processing
System
Cleared Date: 27-JUN-2008
BK870024 Gambro Inc.
23872 Kelsey Road
Barrington, IL 60010
Trade Name:Gambro Welding Device WD2
Cleared Date: 02-NOV-1987
BK820017 Gamma Biologicals, Inc.
3700 Mangum Road
Houston, TX 77092
Trade Name:Omni-Series Control
Cleared Date: 21-JAN-1983
BK830012 Gamma Biologicals, Inc.
3700 Mangum Road
Houston, TX 77092
Trade Name:Gamma Omni Coombs Control Cells
Cleared Date: 13-JUN-1983
BK830014 Gamma Biologicals, Inc.
3700 Mangum Road
Houston, TX 77092
Trade Name:Elu-Kit II
Cleared Date: 25-NOV-1983
BK830019 Gamma Biologicals, Inc.
3700 Mangum Road
Houston, TX 77092
Trade Name:Gamma Microtear System
Cleared Date: 21-SEP-1983
BK830026 Gamma Biologicals, Inc.
3700 Mangum Road
Houston, TX 77092
Trade Name:Gamma Micro-U Plate
Cleared Date: 08-DEC-1983
BK850001 Gamma Biologicals, Inc.
3700 Mangum Road
Houston, TX 77092
Trade Name:Gamma STS-M
Cleared Date: 05-APR-1985
BK850002 Gamma Biologicals, Inc.
3700 Mangum Road
Houston, TX 77092
Trade Name:Gamma STS Red Cell Diluent
Cleared Date: 05-APR-1985
BK850005 Gamma Biologicals, Inc.
3700 Mangum Road
Houston, TX 77092
Trade Name:Gamma STS-A
Cleared Date: 03-OCT-1986
BK850019 Gamma Biologicals, Inc.
3700 Mangum Road
Houston, TX 77092
Trade Name:Gamma Micro-U Accessory Equipment
(Timer Device)
Cleared Date: 20-MAR-1986
BK850020 Gamma Biologicals, Inc.
3700 Mangum Road
Houston, TX 77092
Trade Name:Gamma Micro-U Accessory Equipment
Cleared Date: 20-MAR-1986
BK850021 Gamma Biologicals, Inc.
3700 Mangum Road
Houston, TX 77092
Trade Name:Gamma Micro-U Accessory Equipment
Cleared Date: 20-MAR-1986
BK850024 Gamma Biologicals, Inc.
3700 Mangum Road
Houston, TX 77092
Trade Name:Gamma Micro-U Coombs Wash Solution
Cleared Date: 20-MAR-1986
BK850025 Gamma Biologicals, Inc.
3700 Mangum Road
Houston, TX 77092
Trade Name:Gamma Micro-U Enhancement Reagent
Cleared Date: 20-MAR-1986
BK860024 Gamma Biologicals, Inc.
3700 Mangum Road
Houston, TX 77092
Trade Name:Gamma N-HANCE
Cleared Date: 26-AUG-1986
BK880016 Gamma Biologicals, Inc.
3700 Mangum Road
Houston, TX 77092
Trade Name:GammaZyme-B
Cleared Date: 25-AUG-1988
BK900021 Gamma Biologicals, Inc.
3700 Mangum Road
Houston, TX 77092
Trade Name:Gamma-clone Control
Cleared Date: 26-OCT-1990
BK910001 Gamma Biologicals, Inc.
3700 Mangum Road
Houston, TX 77092
Trade Name:Gamma Peg
Cleared Date: 24-MAR-1992
BK930026 Gamma Biologicals, Inc.
3700 Mangum Road
Houston, TX 77092
Trade Name:Gamma RQC-Kit
Cleared Date: 16-NOV-1993
BK960055 Gamma Biologicals, Inc.
3700 Mangum Road
Houston, TX 77092
Trade Name:Coombs Control Cells (EIgG) Strong
Cleared Date: 23-OCT-1996
BK960056 Gamma Biologicals, Inc.
3700 Mangum Road
Houston, TX 77092
Trade Name:Coombs Control Cells (EIgG) Weak
Cleared Date: 23-OCT-1996
BK960077 Gamma Biologicals, Inc.
3700 Mangum Road
Houston, TX 77092
Trade Name:Gamma Re-ACT Centrifuge
Cleared Date: 18-SEP-1997
BK960078 Gamma Biologicals, Inc.
3700 Mangum Road
Houston, TX 77092
Trade Name:Gamma ReACT Incubator
Cleared Date: 18-SEP-1997
BK960079 Gamma Biologicals, Inc.
3700 Mangum Road
Houston, TX 77092
Trade Name:Gamma ReACT Antibody Detection
Strips
Cleared Date: 18-SEP-1997
BK960080 Gamma Biologicals, Inc.
3700 Mangum Road
Houston, TX 77092
Trade Name:Gamma ReACT Diluent
Cleared Date: 18-SEP-1997
BK960081 Gamma Biologicals, Inc.
3700 Mangum Road
Houston, TX 77092
Trade Name:Gamma ReACT Control Cells (EIgG)
Cleared Date: 18-SEP-1997
BK960090 Gamma Biologicals, Inc.
3700 Mangum Road
Houston, TX 77092
Trade Name:Gamma EGA Kit
Cleared Date: 21-JUL-1997
BK970002 Gamma Biologicals, Inc.
3700 Mangum Road
Houston, TX 77092
Trade Name:Gamma-ReACT workstation
Cleared Date: 30-MAY-1997
BK970003 Gamma Biologicals, Inc.
3700 Mangum Road
Houston, TX 77092
Trade Name:Gamma-ReACT Reader
Cleared Date: 30-MAY-1997
BK970047 Gamma Biologicals, Inc.
3700 Mangum Road
Houston, TX 77092
Trade Name:Olympus System Control Reagent
Cleared Date: 11-DEC-1998
BK060050 Gaymar Industries, Inc.
1700 Pennsylvania Avenue, N.W.
Washington, DC 20006-4706
Trade Name:Medi-Temp III, Model FW600
Blood/Fluid Warmer
Cleared Date: 07-NOV-2006
BK950002 Gen Trak, Inc.
5100 Campus Dr.
Plymouth Meeting, NJ 19462
Trade Name:CQuentials DR DNA Typing Kit
Cleared Date: 15-MAY-1995
BK000051 Gen-Probe
10210 Genetic Center Drive
San Diego, CA 92121-4362
Trade Name:The Chiron Procleix System
Cleared Date: 08-FEB-2002
BK010003 Gen-Probe
10210 Genetic Center Drive
San Diego, CA 92121-4362
Trade Name:CHironProcleix HIV-1/HCV Controls
Cleared Date: 22-FEB-2002
BK010005 Gen-Probe
10210 Genetic Center Drive
San Diego, CA 92121-4362
Trade Name:Chiron Procleix HIV/HCV
Proficiency Panel
Cleared Date: 01-OCT-2001
BK020045 Gen-Probe
10210 Genetic Center Drive
San Diego, CA 92121-4362
Trade Name:Chiron Procleix System
Cleared Date: 21-NOV-2002
BK050007 Gen-Probe
10210 Genetic Center Drive
San Diego, CA 92121-4362
Trade Name:Procleix System
Cleared Date: 29-APR-2005
BK050042 Gen-Probe
10210 Genetic Center Drive
San Diego, CA 92121-4362
Trade Name:Procleix System for the Procleix
WNV Assay
Cleared Date: 15-NOV-2005
BK060012 Gen-Probe
10210 Genetic Center Drive
San Diego, CA 92121-4362
Trade Name:Procleix System
Cleared Date: 15-MAR-2006
BK060021 Gen-Probe
10210 Genetic Center Drive
San Diego, CA 92121-4362
Trade Name:Procleix® TIGRIS® System for use
with the Procleix® WNV Assay
Cleared Date: 20-FEB-2007
BK950018 Genesis BPS, LLC
65 Commerce Way
Hackensack, NJ 07601
Trade Name:TOTAL CONTAINMENT DEVICE (TCD)
Cleared Date: 14-NOV-1995
Cleared Under DENCO, INC.
BK880025 Genetic Design Inc.
7019 Albert Pick Rd.; Suite H
Greensboro, NC 27409
Trade Name:HLA-DR Typing Trays
Cleared Date: 30-DEC-1988
BK870006 Genetic Systems Corporation
3005 First Avenue
Seattle, WA 98121
Trade Name:HLA-B27 Antigen Typing Kit
Cleared Date: 20-JUL-1987
BK900011 Genetic Systems Corporation
3005 First Avenue
Seattle, WA 98121
Trade Name:Genetic Systems Blood Virus
Software
Cleared Date: 15-MAR-1991
BK930031 Genetic Systems Corporation
3005 First Avenue
Seattle, WA 98121
Trade Name:Expresso Cartridge Software for
Blood Virus Applications
Cleared Date: 24-FEB-1994
BK860022 Genetic Testing Institute
1701 W. Wisconsin Avenue, Suite 429
Milwaukee, WI 53233
Trade Name:GTI-60 HLA Typing Trays
GTI-72 HLA Typing Trays
GTI-96 HLA Typing Trays
Cleared Date: 24-FEB-1987
BK910013 Genetic Testing Institute
1701 W. Wisconsin Avenue, Suite 429
Milwaukee, WI 53233
Trade Name:GTI Pep Antibody Enhancement
Solution
Cleared Date: 23-JUN-1992
BK930014 Genetic Testing Institute
1701 W. Wisconsin Avenue, Suite 429
Milwaukee, WI 53233
Trade Name:GTI Reduced Wash Elution Kit
Cleared Date: 28-OCT-1993
BK930032 Genetic Testing Institute
1701 W. Wisconsin Avenue, Suite 429
Milwaukee, WI 53233
Trade Name:GTI ACE Antigen Capture ELISA for
Detection of IgG Antibodies to
Platelet Specific Antibodies
Cleared Date: 20-JUN-1994
BK950004 Genetic Testing Institute
1701 W. Wisconsin Avenue, Suite 429
Milwaukee, WI 53233
Trade Name:GTI-PAK 2 Platelet Antibody
Screening Kit
Cleared Date: 15-MAY-1995
BK950005 Genetic Testing Institute
1701 W. Wisconsin Avenue, Suite 429
Milwaukee, WI 53233
Trade Name:GTI-HLA 1, Class I Antibody
Screening Kit
Cleared Date: 19-MAY-1995
BK960059 Genetic Testing Institute
150 N. Patrick Blvd.
Brookfield, WI 53045
Trade Name:PAKAUTO Platelet Antibody
Screening Kit
Cleared Date: 22-OCT-1998
BK980005 Genetic Testing Institute
150 N. Patrick Blvd.
Brookfield, WI 53045
Trade Name:GTI PAT HPA-1 (PI) Genotyping Kit
Cleared Date: 23-APR-1999
BK000015 Genetic Testing Institute
150 N. Patrick Blvd.
Brookfield, WI 53045
Trade Name:Quick ID Solid Phase ELISA for
detection of Panel Reactive HLA
Class I IgG Antibodies (PRA)
Cleared Date: 17-OCT-2000
BK000031 Genetic Testing Institute
150 N. Patrick Blvd.
Brookfield, WI 53045
Trade Name:GTI-MACE (Modified Capture Elisa)
Cleared Date: 29-JAN-2001
BK990043 Genetic Testing Institute
150 N. Patrick Blvd.
Brookfield, WI 53045
Trade Name:B-Screen Solid Phase ELISA Assay
for Detection of IgG Antibodies to
HLA Class II Antigens
Cleared Date: 02-OCT-2000
BK010010 Genetic Testing Institute
150 N. Patrick Blvd.
Brookfield, WI 53045
Trade Name:Quik-ID Class II
Cleared Date: 01-OCT-2001
BK050026 Greiner Bio One North America, Inc.
4238 Capital Drive
Monroe, NC 28110
Trade Name:Greiner Vacuette No Additive Tubes
Cleared Date: 07-JUL-2005
BK050028 Greiner Bio One North America, Inc.
4238 Capital Drive
Monroe, NC 28110
Trade Name:Greiner Vacuette Clot Activator
Tube
Cleared Date: 07-JUL-2005
BK030001 Greiner Bio-One GmbH
4238 Capital Drive
Monroe, NC 28112
Trade Name:Greiner Vacuette EDTA K3 Tube
Cleared Date: 26-FEB-2003
BK030032 Greiner Bio-One GmbH
4238 Capital Drive
Monroe, NC 28112
Trade Name:Vacuette EDTA K2 Tube
Cleared Date: 18-JUL-2003
BK840002 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Alpha Plasma Pooling Bottle II
Cleared Date: 13-JUL-1984
BK840007 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Alpha Plasma Pooling Bottle
Cleared Date: 21-SEP-1984
BK840014 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Haemonetics V50 Surge Procedure
Cleared Date: 06-JUL-1984
BK840021 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Haemonetics PCS Plasma Collection
System
Cleared Date: 03-JAN-1985
BK840022 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Haemonetics 115 Cell Washer
Cleared Date: 24-OCT-1984
BK840025 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Haemonetics 16 Programmed Pump
Cleared Date: 14-NOV-1984
BK860013 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:603-EX Extended Storage
Plateletpheresis Set
Cleared Date: 06-NOV-1987
BK870026 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Haemonetics Ultralite Plasma
Collection System
Cleared Date: 17-MAR-1988
BK890007 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Haemonetics 705 Time Saver
Platelet Pack
Cleared Date: 13-AUG-1990
BK900019 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Alpha Plasma Pooling Bottle II
(Significant Rev.)
Cleared Date: 14-AUG-1990
BK900022 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Plasma Pooling Bottle II
(Significant Revision)
Cleared Date: 11-OCT-1990
BK900027 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:790 ESP Collection Set
Cleared Date: 19-APR-1991
BK910009 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Alpha Plasma Pooling Bottle II
(Significant Rev.)
Cleared Date: 08-SEP-1991
BK920012 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:705FTSPP/790F
Cleared Date: 16-SEP-1992
BK920039 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Plasma Collection System PCS2
Cleared Date: 02-SEP-1993
BK930007 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:790 Extended Storage Platelet
Collection Set
Cleared Date: 16-NOV-1993
BK930008 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:791 A Fresh Frozen Plasma
Collection Set (Latham Bowl)
Cleared Date: 16-NOV-1993
BK930009 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:791 Fresh Frozen Plasma Collection
Set (Blow Molded Bowl)
Cleared Date: 16-NOV-1993
BK930013 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:MCS Plus & Disp.Sets, List No.
890,790,791A,791
Cleared Date: 12-JAN-1994
BK940064 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Red Cell and Plasma Apheresis
Set/FOR USE WITH MCP PLUS
Cleared Date: 23-OCT-1995
BK950001 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Haemonetics RBC Apheresis Set for
MCS+(NO.831)
Cleared Date: 22-APR-1996
BK950006 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:List #890F Extended Storage Plt
Collection Set
Cleared Date: 09-JUN-1995
BK950007 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:ESP White Cell Filter (No. 790F)
Cleared Date: 28-JUN-1995
BK950033 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Haemonetics PCS2
Cleared Date: 16-APR-1996
BK950034 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Double Product Collection (SDP-3)
Cleared Date: 15-FEB-1996
BK950063 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Red Blood Cell and Plasma
Collection Set for the MCS Plus
#823
Cleared Date: 22-JUL-1996
BK960006 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Double Unit Red Blood Cell
Aphersis Set MCS #833
Cleared Date: 15-OCT-1996
BK960022 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:MCS+Double Unit RBC Apheresis Set-
Dry(LN832)
Cleared Date: 16-APR-1997
BK960023 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:MCS+Red Cell & Plasma Apheresis
Set - Dry(LN822)
Cleared Date: 16-APR-1997
BK960095 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:MCS+Apheresis System (LN8150)
Cleared Date: 11-APR-1997
BK970029 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Alpha Plasma Pooling Bottle II
(60-2227S)
Cleared Date: 07-JAN-1998
Cleared Under Alpha Therapeutic
Corporation
BK970034 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:LN994CF
Cleared Date: 15-SEP-1998
BK970041 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Haemonetics Corp. Extended Storage
Platelet & Plasma Apheresis Set
with Saline Compensation & Pall
LRF-XL (LN994C)
Cleared Date: 16-NOV-1998
BK980040 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Citroflex Plalsticized PVC
Extended Storage Platelet Bag
Cleared Date: 07-JAN-1999
BK000002 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Model 215 Automated
Glycerolization and
Deglycerolization System
Cleared Date: 04-MAY-2001
BK990033 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:MCS+ LN8150
Cleared Date: 20-JAN-2000
BK990044 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Haemonetics LN832F
Two Unit Red Cells Disposable Set
with Leukocyte reduction Filter
Cleared Date: 27-OCT-2000
BK000048 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Haemonetics LN832F
Cleared Date: 09-APR-2001
BK010035 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:MCS+ Mobile Collection System
Cleared Date: 20-DEC-2002
BK020001 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Plasma Pooling Bottle II
Cleared Date: 29-MAR-2002
BK030031 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Haemonetics Model 215 Automated
Glycerolyzation /
Deglycerolyzationand Cell Washing
System
Cleared Date: 10-SEP-2003
BK030062 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Haemonetics Model 215 Automated
Glycerolization/deglycerolization
System
Cleared Date: 10-DEC-2003
BK030084 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Haemonetics LN994CF-CPP-BA
Extended Storage Platelet and
Plasma Apheresis Set
Cleared Date: 09-JAN-2004
BK040001 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Haemonetics 4mL Sampling System
Cleared Date: 27-FEB-2004
BK040020 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Haemonetics LN994CF-BA Extended
Storage Platelet and Plasma
Apheresis Set with Leukocyte
Reduction Filter, and 4 mL
Sampling System.
Cleared Date: 29-MAR-2004
BK040025 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:PCS2 Plasma Collection System
Cleared Date: 02-JUN-2004
BK040041 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Haemonetics MCS+8150 Apheresis
System
Cleared Date: 12-JUL-2004
BK040077 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Haemonetics Model 215 Automated
Glycerolization/Deglycerolization
System
Cleared Date: 21-DEC-2004
BK050006 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:ACP 215
Glycerolization/Deglycerolization
System
Cleared Date: 14-APR-2005
BK050047 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:MCS+9000, SDP revision E software,
994CF-CPP series disposable sets
Cleared Date: 21-NOV-2005
BK050048 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Haemonetics MCS+ 8150 Apheresis
System
Cleared Date: 27-SEP-2005
BK060008 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Haemonetics ACP 215
Glycerolization/Deglycerolization
System
Cleared Date: 23-MAY-2006
BK060023 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Haemonetics MCS+ 8150 Apheresis
System
Cleared Date: 23-MAY-2006
BK060033 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Haemonetics PCS 2 Plasma
Collection System, Wireless (W)
Capable Modification-
Cleared Date: 27-MAR-2008
BK060057 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Cymbal Automated Blood Collection
System
Cleared Date: 28-FEB-2007
BK070019 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Haemonetics PCS2 Plasma Collection
System
Cleared Date: 23-MAY-2007
BK080001 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184-9144
Trade Name:PCS2 Plasma Collection
System_Revision K software
Cleared Date: 28-MAY-2008
BK080025 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
Trade Name:Cymbal Automated Blood Collection
System
Cleared Date: 15-AUG-2008
BK000037 Harvest Technologies
40 Grissom Road
Plymouth, MA 02360
Trade Name:Harvest PRP Separation System
Cleared Date: 05-FEB-2001
BK050001 Healthcare Management Systems, Inc.
3102 West End Avenue, Suite 400
Nashville, TN 37203
Trade Name:Monitor Blood Administration
Module - Release 24.0
Cleared Date: 28-SEP-2005
BK030049 Healthcare-ID
1635 Barclay Blvd.
Buffalo Grove, IL 60089
Trade Name:Donor-ID - version 2.5
Cleared Date: 31-OCT-2003
BK060058 Healthcare-ID
1635 Barclay Blvd.
Buffalo Grove, IL 60089
Trade Name:Donor-ID - 3.0
Cleared Date: 08-FEB-2007
BK820013 Helmer Labs., Inc.
5415 Distribution Drive
Fort Wayne, IN 46825
Trade Name:Platelet Agitator
Cleared Date: 29-OCT-1982
BK820022 Helmer Labs., Inc.
5415 Distribution Drive
Fort Wayne, IN 46825
Trade Name:Helmer Incubator-Agitator
Cleared Date: 03-JAN-1983
BK840027 Helmer Labs., Inc.
5415 Distribution Drive
Fort Wayne, IN 46825
Trade Name:Helmer Platelet Agitator PF108
Helmer Platelet Agitator PF54
Cleared Date: 16-APR-1985
BK850014 Helmer Labs., Inc.
5415 Distribution Drive
Fort Wayne, IN 46825
Trade Name:PLATELET FLATBED AGITATOR MODEL
PF456
Cleared Date: 30-AUG-1985
BK850015 Helmer Labs., Inc.
5415 Distribution Drive
Fort Wayne, IN 46825
Trade Name:Helmer Incubator Models PC1000
Helmer Incubator Models PC2000
Helmer Incubator Models PC3000
Cleared Date: 20-SEP-1985
BK850018 Helmer Labs., Inc.
5415 Distribution Drive
Fort Wayne, IN 46825
Trade Name:Tube Stripper
Cleared Date: 21-OCT-1985
BK940051 Helmer Labs., Inc.
5415 Distribution Drive
Fort Wayne, IN 46825
Trade Name:Helmer Water Plasma Thawer
Cleared Date: 03-MAR-1995
BK020029 Helmer Labs., Inc.
15425 Herriman Boulevard
Noblesville, IN 46060
Trade Name:UltraCW (with Software version
3.13)
Cleared Date: 04-OCT-2002
BK890028 Hemagen Diagnostics, Inc.
9033 Red Branch Road
Columbia, MD 21045
Trade Name:Olypmus PK CMV System
Cleared Date: 11-DEC-1989
BK940035 Hemagen Diagnostics, Inc.
9033 Red Branch Road
Columbia, MD 21045
Trade Name:Olympus PK TM CMV System & System
Controls
Cleared Date: 15-JUL-1996
BK950008 Hemasure, Inc.
140 Locke Drive
Marlborough, MA 01752
Trade Name:LeukoNet Pre Storage
Leukodepletion Filteration System
Cleared Date: 28-JUN-1995
BK980014 Hemasure, Inc.
140 Locke Drive
Marlborough, MA 01752
Trade Name:HemaSure r|LS Pre-Storage
Leukoreduction Filtration System
for Red Blood Cells
HemaSure r|LS Pre-Storage
Leukoreduction Filtration System
with spike for Red Blood Cells
Cleared Date: 27-MAY-1999
BK070024 Hemerus Medical, LLC
5000 Township Parkway
Saint Paul, MN 55110
Trade Name:HEMERUS Medical LLC
Cleared Date: 23-AUG-2007
BK060048 HemoCue AB
Kuvettgatan 1
Angelholm, Sweden SE-262 71
Trade Name:HemoCue Hb 301 System
Cleared Date: 05-OCT-2006
BK000043 HemoCue, Incorporated
9229 Cranford Drive
Potomac, MD 20854
Trade Name:HemoCue Low Hemoglobin Analyzing
System
Cleared Date: 09-APR-2001
BK030020 HemoCue, Incorporated
9229 Cranford Drive
Potomac, MD 20854
Trade Name:Donor Hemoglobin Checker System
Cleared Date: 17-APR-2003
BK030067 HemoCue, Incorporated
9229 Cranford Drive
Potomac, MD 20854
Trade Name:HemoCue Donor Hb Checker Control
Cleared Date: 19-DEC-2003
BK040031 Hemosystem, S.A.
45, Cours Gouffe
13006 Marseille, France
Trade Name:Scansytem bacterial detection
device
Cleared Date: 23-SEP-2004
BK900024 Heraeus Inc.
111A Corporate Blvd, S.
Plainfield, NJ 07080
Trade Name:Cryofuge 6000
Cleared Date: 05-NOV-1992
BK900015 I. B. G. Systems Inc.
P.O. Box 5306
Laytonsville, MD 20882
Trade Name:Inverness Blood Grouping System
Cleared Date: 20-SEP-1990
BK920019 I. B. G. Systems Inc.
P.O. Box 5306
Laytonsville, MD 20882
Trade Name:Inverness Automated Antibody
Screening System
Cleared Date: 26-MAR-1993
BK930025 ICU MEDICAL IN