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  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
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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