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  6. Cleared 510(k) Submissions with Supporting Documents - 2018
  1. Approved Blood Products

Cleared 510(k) Submissions with Supporting Documents - 2018

This list includes cleared 510(k) submissions for 2018 for which we have supporting documents available, and reflects the information as of the clearance date. It is not updated with regard to applicant or application status change.

The clearances are listed by clearance date in reverse chronological order.

510(k) Number Applicant Device Name Decision Date
BK180293 Fresenius Kabi AG
Lake Zurich, IL
Plasma Bottle with Locking Luer Adapter 12/21/2018
BK180262 Diagnostic Grifols, S.A.
Barcelona, Spain
DG Gel 8 Neutral 12/20/2018
BK180260 Diagnostic Grifols, S.A.
Barcelona, Spain
Erytra Eflexis 12/20/2018
BK180254 Fresenius Kabi AG
Lake Zurich, IL
Glycerolyte 57 Solution, 400 mL; Glycerolyte 57 Solution, 500 mL 12/3/2018
BK180266 bioMérieux, Inc.
Hazelwood, MO
BACT/ALERT® BPA Culture Bottle; BACT/ALERT® BPN Culture Bottle 11/29/2018
BK180188 PuriBlood Medical Co. Ltd.
Taiwan (R.O.C.)
Leukocyte reduction filter for red blood cells 11/23/2018
BK180278 OriGen Biomedical, Inc.
Austin, TX
OriGen Cryostore Multi-Chamber Freezing Bags 11/21/2018
BK170136 Healeon Medical, Inc.
Newbury Park, CA
Healeon HD PRP 11/21/2018
BK180247 Immucor, Inc.
Norcross, GA
Capture-CMV 11/20/2018
BK180198 ThermoGenesis, Inc.
Rancho Cordova, CA
AXP® II AutoXpress® Platform 11/14/2018
BK180245 Data Innovations LLC
South Burlington, VT
Instrument Manager V8.16.10 11/8/2018
BK180243 Immucor, Inc.
Norcross, GA
NEO Iris (Software Version 3.0) 11/7/2018
BK180240 Biomat USA, Inc.
Los Angeles, CA
GDS (Grifols Donation System), version 1.0 11/5/2018
BK180268 Fresenius Kabi AG
Lake Zurich, IL
Aurora XI Plasmapheresis System, version 1.2 11/2/2018
BK180246 Carter BloodCare
Bedford, TX
Blood Bank Information System (BBIMS) version 2.06.00 11/1/2018
BK180232 MAK-SYSTEM SA International Group
Paris, France
Patient Health Software (P.H.S) Version 2.0 10/18/2018
BK170092 Progenika Biopharma, S. A.
ID CORE CONTROL 10/11/2018
BK180229 Delcon S.R.L
HemoMix 3 with DCSX Software 10/4/2018
BK180227 Department of Veterans Affairs
Hines, IL
VistA Blood Establishment Computer (VBECS) Version 2.3.0 10/1/2018
BK180226 Bio-Rad Medical Diagnostics GmbH
Redmond, WA
IH-Com V5.0 9/28/2018
BK180225 Bio-Rad Medical Diagnostics GmbH
Redmond, WA
IH-Reader 24 9/28/2018
BK180219 Medical Information Technology, Inc.
Westwood, MA
MEDITECH Expanse Blood Bank 9/12/2018
BK180231 Terumo BCT, Inc.
Lakewood, CO
Trima Accel® Automated Blood Collection System 8/16/2018
BK180230 Fresenius Kabi AG
Lake Zurich, IL
DXT Data Management System, Software Version 3.1 8/13/2018
BK180211 Becton, Dickinson & Company
Sparks, MD
BD BACTEC™ Platelet Aerobic/F Culture vials; BD BACTEC™ Platelet Anaerobic/F Culture Vials 8/8/2018
BK180209 Haemonetics Corporation
Braintree, MA
SafeTrace Tx 4.0.0 8/7/2018
BK180220 Immucor, Inc.
Norcross, GA
Galileo Echo® 7/17/2018
BK180204 Royal Biologics, LLC Royal MaxxPRP Concentration System 7/12/2018
BK180180 Arthrex, Inc.
Naples, FL
Arthrex Angel System Kit 7/5/2018
BK180200 Mediware Information Systems, Inc.
Lenexa, KS
LifeTrak®2018 7/3/2018
BK180181 Immucor GTI Diagnostics, Inc.
Waukesha, WI
DonorScreen-HLA® Class I and Class II 6/14/2018
BK170095 RedDress Ltd
Philadelphia, PA
RD1 System 6/14/2018
BK170150 Biowy Corporation
Lake Forest, CA
Biowy Freezing Bags 5/11/2018
BK170144 Arthrex, Inc.
Naples, FL
Thrombinator System for use with the Arthrex Angel concentrated Platelet Rich Plasma (PRP) System 5/10/2018
BK180175 Bio-Rad Medical Diagnostic GmbH
Redmond, WA
TANGO infinity Software Version 1.5 5/1/2018
BK180174 Bio-Rad Medical Diagnostic GmbH
Redmond, WA
IH-Com V5.0 5/1/2018
BK170135 Immucor, Inc.
Norcross, GA
Echo Lumena™ 4/27/2018
BK170132 Immucor, Inc.
Norcross, GA
Galileo Echo® (v.2.0) 4/27/2018
BK170149 Immunetics, Inc.
Boston, MA
BacTx® Bacterial Detection Kit 4/16/2018
BK170157 Terumo BCT, Inc.
Lakewood, CO
Trima Accel Blood Collection System 4/6/2018
BK180185 Haemonetics Corporation
Braintree, MA
PCS 300 Plasma Collection System 3/27/2018
BK160084 Diagast
Minneapolis, MN
Neg Control 2/2/2018
BK170142 bioMerieux, Inc.
Hazelwood, MO
BacT/ALERT BPA Culture Bottle; BacT/ALERT BPN Culture Bottle 2/1/2018
BK170138 Ethicon Inc.
Somerville, NJ
EVICEL™ Laparoscopic Airless Spray Accessory (35cm Rigid) 1/26/2018
BK170141 Helmer Inc.
Noblesville, IN
UltraCW®II Automatic Cell Washing System 1/22/2018
BK170162 Grifols Diagnostic Solutions, Inc.
Emeryville, CA
Procleix Xpress® System (Software v3.0) 1/18/2018
BK170108 Alliance Partners, LLC
San Antonio, TX
Cyclone Concentrating System 1/2/2018