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  6. Cleared 510(k) Submissions with Supporting Documents - 2021
  1. Substantially Equivalent 510(k) Device Information

Cleared 510(k) Submissions with Supporting Documents - 2021

This list includes cleared 510(k) submissions for 2021 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
BK210639 Beckman Coulter Inc.
Miami, FL		 Stem Kit Reagents, stemCXP System 12/15/2021
BK210574 Immucor, Inc.
Norcross, GA		 LIFECODES LSA Class II 11/19/2021
BK210573 Immucor, Inc.
Norcross, GA		 LIFECODES LSA Class I 11/19/2021
BK210572 Immucor, Inc.
Norcross, GA		 BK210572 - MATCH IT! Antibody 11/19/2021
BK210621 NanoEntek, Inc.
Korea		 rControl RBC and PLT 10/28/2021
BK210620 Alliance Technologies, LLC
Phoenix, AZ		 BloodRelay 1.1.0 10/4/2021
BK210607 SCC Soft Computer
Clearwater, FL		 SoftDonor Version 4.5.5.0 9/14/2021
BK210605 Immucor, Inc.
Norcross, GA		 Galileo NEO 9/3/2021
BK210600 Immucor, Inc.
Norcross, GA		 NEO Iris 9/3/2021
BK210593 BIQ-Health Solutions, Lda.
Portugal		 Btrac 8/13/2021
BK210558 LUVO Medical Technologies, Inc.
Ontario, Canada		 World PRP 7/23/2021
BK210570 RedDress Ltd
Israel		 RD2 Ver.02 System 6/22/2021
BK210559 Sysmex America Inc.
Lincolnshire, IL		 Sysmex XN-10 Automated Hematology Analyzer 5/27/2021
BK210564 Ortho-Clinical Diagnostics, Inc.
Raritan, NJ		 ORTHO VISION® Max Analyzer 5/13/2021
BK210557 Ortho-Clinical Diagnostics, Inc.
Raritan, NJ		 ORTHO VISION® Analyzer 5/13/2021
BK210563 Royal Biologics, Inc
Hackensack, NJ		 Royal Maxx Autologous PRP Concentration System 4/16/2021
BK210556 Sunquest Information Systems, Inc.
Tucson, AZ		 Sunquest Transfusion Manager™ Version 3.0 4/16/2021
BK210562 Immucor, Inc.
Norcross, GA		 Galileo NEO 4/12/2021
BK210560 Immucor, Inc.
Norcross, GA		 NEO Iris 4/12/2021
BK200549 Ortho-Clinical Diagnostics, Inc.
Raritan, NJ		 ORTHO Optix™ Reader 3/10/2021
BK200543 Ranfac Corporation
Avon, MA		 Ranfac Autologous Platelet Separator 2/24/2021
BK200542 Immucor, Inc.
Norcross, GA		 Capture-CMV® 2/8/2021
BK200539 Arlington Scientific, Inc.
Springville, UT		 ASI Automated RPR test for Syphilis for use on the ASI Evolution 2/2/2021
BK200471 Reapplix A/S
Denmark		 Reapplix 3C Patch System 1/13/2021
BK200548 Bio-Rad Medical Diagnostics GmbH
Dreieich, Germany		 IH-1000 1/12/2021
BK200546 One Lambda, Inc.
Canoga Park, CA		 LABScreen Multi 1/6/2021
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