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  6. Cleared 510(k) Submissions with Supporting Documents - 2017
  1. Approved Blood Products

Cleared 510(k) Submissions with Supporting Documents - 2017

This list includes cleared 510(k) submissions for 2017 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
BK170114 Arlington Scientific, Inc.
Springville, UT
ASI Automated RPR test for Syphilis for use on the ASI Evolution 12/28/2017
BK170075 Bio-Rad Medical Diagnostic GmbH
Redmond, WA
IH-Basic QC 12/20/2017
BK170128 Reichert, Inc.
Depew, NY
TS Meter-DSP 12/19/2017
BK170066 Bio-Rad Medical Diagnostics GmbH
Dreieich, Germany
IH-Incubator L 12/18/2017
BK170065 Bio-Rad Medical Diagnostics GmbH
Dreieich, Germany
IH-Centrifuge L 12/18/2017
BK170064 Bio-Rad Medical Diagnostics GmbH
Dreieich, Germany
IH-Internal QC 12/18/2017
BK170028 Baxalta US, Inc.
Westlake Village, CA
myPKFiT for ADVATE 12/14/2017
BK170102 ITL Corporation, LTD
Abington, MA
Samplok® Segment Sampler 11/27/2017
BK170096 Cascade Medical Enterprises, LLC
Chapel Hill, NC
Cascade Medical Fibrinet® System 11/21/2017
BK160095 MacoProductions S.A.S
Duluth, GA
MacoMix HM20 and Hemolog 6 11/15/2017
BK170085 MacoProductions S.A.S.
Duluth, GA
MacoPress Smart (MPS) and DMS Plus 11/09/2017
BK160071 STRATEC Biomedical UK Limited
Southington, CT
Aurora Enterprise 10/30/2017
BK160124 STRATEC Biomedical UK Limited
Southington, CT
ORTHO CONNECT™ 10/17/2017
BK170099 Fresenius Kabi USA, LLC
Lake Zurich, IL
AMICUS Separator System 10/10/2017
BK170053 One Lambda, Inc.
Canoga Park, CA
LABType™ XR and CWD DNA Typing Test 10/05/2017
BK170098 Terumo BCT, Inc.
Lakewood, CO
TSCD®-II Sterile Tubing Welder with or without Trucise Total System™ 09/29/2017
BK170071 Bio-Rad Laboratories, Inc.
Redmond, WA
IH-Com V5.0 09/26/2017
BK170072 Fresenius Kabi AG
Lake Zurich, IL
DXT Data Management System v3.0 09/26/2017
BK170057 Fresenius Kabi AG
Lake Zurich, IL
Aurora Xi Plasmapheresis System 08/25/2017
BK170045 Haemonetics Corporation
Braintree, MA
PCS 300 Plasma Collection System 07/25/2017
BK170033 Baxter Healthcare Corporation
Round Lake, IL
Duploject, Duo Set and Duo Set A 07/24/2017
BK170030 Fresenius Kabi AG
Lake Zurich, IL
Bone Marrow Collection Kit with Flexible Pre-Filter and Inline Filters and Bone Marrow Collection Stand 07/24/2017
BK170067 Immucor, Inc.
Norcross, GA
Galileo Neo® Automated Blood Bank System 07/19/2017
BK170059 Terumo BCT, Inc.
Lakewood, CO
Trima Accel ® Automated Blood Collection System 07/07/2017
BK170032 Epics System Corporation
Verona, WI
Blood Product Administration Module Version 2-2017 06/28/2017
BK170013 Alba Bioscience Limited
United Kingdom
AlbaQ-Chek® Simulated Whole Blood Controls, Model Z498 05/09/2017
BK170019 Bio-Rad Medical Diagnostic GmbH
Redmond, WA
IH-1000 V04.04.52 05/05/2017
BK170021 Bio-Rad Medical Diagnostic GmbH
Redmond, WA
IH-Com V5.0 05/05/2017
BK160125 STRATEC Biomedical UK Limited
Southington, CT
Procleix® NAT Manager® v1.2 Software 04/25/2017
BK160113 STRATEC Biomedical UK Limited
Southington, CT
cobas Synergy Software (v 1.0) 04/19/2017
BK160112 Fresenius Kabi USA, LLC
Lake Zurich, IL
AMICUS Separator System 04/07/2017
BK160087 Verax Biomedical Inc
Worcester, MA
Platelet PGD® Test System 04/06/2017
BK170002 Reapplix ApS
Birkerod, Denmark
3C Patch System 04/03/2017
BK170001 Fenwal, Inc.
Lake Zurich, IL
Alyx Component Collection System 04/03/2017
BK160081 Hemo bioscience, Inc.
Morrisville, NC
MQC-CAT 03/30/2017
BK160017 One Lambda, Inc.
Canoga Park, CA
HLA Fusion™ Software Version 4.0 03/08/2017
BK160018 One Lambda, Inc.
Canoga Park, CA
LABType™ XR and CWD DNA Typing Test 03/06/2017
BK160079 Hemo bioscience, Inc.
Morrisville, NC
MQC 02/27/2017