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  6. Cleared 510(k) Submissions with Supporting Documents - 2016
  1. Approved Blood Products

Cleared 510(k) Submissions with Supporting Documents - 2016

This list includes cleared 510(k) submissions for 2016 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
BK160116 Terumo BCT, Inc
Lakewood, CO
Trima Accel® Automated Blood Collection System 12/23/2016
BK160108 Terumo BCT, Inc
Lakewood, CO
TSCD®-II Sterile Tubing Welder with or without Trucise Total System 11/23/2016
BK160103 BioLife Plasma Services L.P. – Baxalta US Inc.
Vernon Hills, IL
Automated Plasma Dispositioning System (APDS) Version 2.0 11/15/2016
BK160045 Alliance Partners, LLC
San Antonio, TX
Cyclone® Platelet Rich Plasma (PRP) Concentrating System 11/04/2016
BK160061 Micro Typing Systems, Inc
Pompano Beach, FL
MTS™ Buffered Gel Card; MTS™ Monoclonal Control Card 10/21/2016
BK160058 Ortho-Clinical Diagnostics, Inc.
Raritan, NJ
ORTHO VISION™ Max Analyzer 10/21/2016
BK140106 Bio-Rad Medical Diagnostics GmbH
Germany
IH-1000 10/20/2016
BK140107 Bio-Rad Medical Diagnostics GmbH
Germany
IH-COM 10/20/2016
BK140138 Bio-Rad Medical Diagnostics GmbH
Germany
IH-Card Neutral 10/20/2016
BK140139 Bio-Rad Medical Diagnostics GmbH
Germany
IH-Card Control 10/20/2016
BK140196 Roche Molecular Systems, Inc.
Pleasanton, CA
cobas® 6800 System and cobas p 680 Instrument 10/20/2016
BK140195 Roche Molecular Systems, Inc.
Pleasanton, CA
cobas® 8800 System and cobas p 680 Instrument 10/20/2016
BK140116 OriGen Biomedical
Austin, TX
Origen Transfer Bag 10/19/2016
BK160044 Thermo Electron LED GmbH
Asheville, NC
Thermo Scientific CW3 Cell Washer 10/07/2016
BK160066 Mediware Information Systems, Inc.
Lenexa, KS
HCLL™ Transfusion 2015 R2 09/30/2016
BK150307 BD Biosciences
San Jose, CA
BD FACSVia™ System with BD Leucocount Reagent Assay 09/16/2016
BK160052 Haemonetics Corporation
El Dorado Hills, CA
InstaMatch 1.0.0 08/25/2016
BK160039 Healthcare-ID, Inc.
Buffalo Grove, IL
Donor-ID™ 3.2 (integrated with iCASI App Android) 7/28/2016
BK160028 Fresenius Kabi AG
Lake Zurich, IL
Aurora Xi Plasmapheresis System 06/21/2016
BK150314 Pall Corporation
Port Washington, NY
Briostor Transfer/Freezing Bag Set 06/16/2016
BK160042 Fresenius Kabi
Lake Zurich, IL
Bone Marrow Collection Kit and Stand 06/09/2016
BK160012 Fresenius Kabi AG
Lake Zurich, IL
Aurora Plasmapheresis System Software Version 1.3 05/19/2016
BK160019 Haemonetics Corporation, Software Solutions
Eldorado Hills, CA
ElDorado Donor 4 Next Generation Donor Management Solution 1.0.0 05/17/2016
BK160027 Haemonetics Manufacturing, Inc
Covina, CA
Acrodose™ PL System 05/16/2016
BK150302 Immucor Transplant Diagnostics, Inc.
Stamford, CT
LIFECODES HLA-DQA1/B1 SSO Typing Kit; LIFECODES HLA-DPA1/B1 SSO Typing Kit 05/11/2016
BK150343 Immucor Transplant Diagnostics, Inc.
Stamford, CT
LIFECODES MATCH IT!TMDNA Software v1.2 05/11/2016
BK160011 Blood Bank Computer Systems, Inc.
Auburn, WA
ABO Express, Version 2.0.0 04/26/2016
BK160035 Immucor GTI Diagnostics, Inc.
Waukesha, WI
LIFECODES LifeScreen Deluxe (LMX) 04/21/2016
BK150357 Fresenius Kabi USA LLC
Lake Zurich, IL
Amicus Separator System 4/20/2016
BK160004 LifeSouth Community Blood Centers, Inc.
Gainesville, FL
Integrated Blood Bank Information System (IBBIS), Version 4.0 03/29/2016
BK160005 Sunquest Information Systems, Inc.
Tucson, AZ
Sunquest Blood Bank and Blood Donor, version 8.0 03/25/2016
BK120014 One Lambda, Inc.
Canoga Park, CA
HLA Fusion™ Software, Version 3.0 03/22/2016
BK070070 One Lambda, Inc.
Canoga Park, CA
HLA Fusion Software v 1.0 03/22/2016
BK150360 Haemonetics Corporation Software Solutions
Eldorado Hills, CA
SafeTrace Tx 3.12.0 03/11/2016
BK150330 Haemonetics Corporation Software Solutions
Eldorado Hills, CA
NextGen 3.0.0 03/03/2016
BK140211 Reapplix ApS
Birkerod, Denmark
3C Patch System 02/24/2016
BK150347 BioLife Plasma Services L.P.
Deerfield, IL
Lookback Notification System (LNS), Version 1.0 02/12/2016