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  1. Substantially Equivalent 510(k) Device Information

Cleared 510(k) Submissions with Supporting Documents - 2019

This list includes cleared 510(k) submissions for 2019 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
BK190379 Diagnostic Grifols, S.A.
Barcelona, Spain
DG Reader Net 10/11/2019
BK190361 Alliance Technologies, LLC.
Phoenix, AZ
BloodRelay 1.0.0 9/17/2019
BK180301 Newmarket Biomedical Ltd.
United Kingdom
PK7400 TP HA Controls and PK7400 TP HA Reagent 8/1/2019
BK190368 Fresenius Kabi AG
Lake Zurich, IL
Aurora Plasmapheresis System, Software Version 2.1 7/26/2019
BK190363 Timestrip UK Ltd.
United Kingdom
Timestrip® Blood Temp 10 (BT10) 7/19/2019
BK190362 Fresenius Kabi AG
Lake Zurich, IL
Plasmalink Bottle with Locking Luer Adapter 7/19/2019
BK190339 Micro Typing Systems Inc.
Raritan, New Jersey
MTS™ Buffered Gel Card 7/8/2019
BK190338 Ortho-Clinical Diagnostics, Inc.
Raritan, New Jersey
ORTHO VISION® Analyzer 7/8/2019
BK190337 Immucor, Inc.
Norcross, GA
Galileo NEO 6/19/2019
BK190324 ETHICON Inc.
Somerville, NJ
VISTASEAL Laparoscopic Dual Applicator (35 cm Rigid or 45 cm Flexible) 6/5/2019
BK190351 Fresenius Kabi USA, LLC
Lake Zurich, IL
ALYX Component Collection System 6/4/2019
BK190332 Terumo BCT, Inc.
Lakewood, CO
Trima Accel Automated Blood Collection System 5/22/2019
BK190322 OrSense Ltd.
Israel
NBM-200 Pulse Oximeter and Hemoglobin Monitor 5/9/2019
BK190312 Bio-Rad Medical Diagnostics GmbH
Redmond, WA
TANGO infinity 04/24/2019
BK180287 Ethicon, Inc.
Somerville, NJ
VISTASEAL Dual Applicator 4/10/2019
BK180252 APEX Biologix
Murry, UT
XCELL PRP™ Platelet Concentrating System 60ml 4/5/2019
BK180275 Bio-Rad Medical Diagnostics GmbH
Redmond, WA
IH-Com V5.0 3/21/2019
BK180274 Bio-Rad Medical Diagnostics GmbH
Redmond, WA
IH-500 Analyzer 3/21/2019
BK180299 Arthrex, Inc.
Naples, FL
Arthrex Thrombinator System 3/7/2019
BK180286 Alba Bioscience Limited
United Kingdom
ALBAcyte® IgG Sensitized Red Blood Cells II 2/5/2019
BK180306 MacoProductions S.A.S.
Duluth, GA
MacoPress Smart Smarter and DMS Plus 1/24/2019
BK180258 Terumo BCT, Inc.
Lakewood, CO
Vista Information System 1/18/2019
BK180280 Medion Grifols Diagnostics AG
Spain
DG Gel Essential Control 1/17/2019