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  6. Cleared 510(k) Submissions with Supporting Documents - 2022
  1. Substantially Equivalent 510(k) Device Information

Cleared 510(k) Submissions with Supporting Documents - 2022

This list includes cleared 510(k) submissions for 2022 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
Paris, France
st’rim, macro st'rim, mini st’rim and nano st’rim 8/26/2022
BK210658 Terumo BCT, Inc.
Lakewood, CO 80215
IMUGARD® WB PLT Platelet Pooling Set 8/26/2022
BK220670 Immucor, Inc.
Norcross, GA
Galileo NEO® 7/26/2022
BK220669 Immucor, Inc.
Norcross, GA
NEO Iris® 7/26/2022
BK210584 GenesisBPS, LLC
Ramsey, NJ
Genesis RapidWeld II STW, model GRW-430-02 7/15/2022
BK210661 RegenLab SA
Avon, Minnesota
RegenKit-Wound Gel-2 7/8/2022
BK220724 Ortho-Clinical Diagnostics, Inc.
Raritan, NJ
ORTHO Optix™ Reader 6/24/2022
BK210653 Millipore (UK) Ltd.
United Kingdom
ORTHO™ Daily QC Simulated Whole Blood Quality Control Kit 6/7/2022
BK210631 Sysmex America, Inc.
Lincolnshire, IL
Sysmex XN-10 Automated Hematology Analyzer 5/23/2022
BK200540 Arteriocyte Medical Systems, Inc.
Hopkinton, MA
Precise Cell Concentration System 3/17/2022
BK220674 MicroAire Surgical Instruments, LLC.
Charlottesville, VA
MicroAire LipoFilter® System 3/16/2022
BK210635 Terumo BCT, Inc.
Lakewood, CO
Rika Plasma Donation System; Rika Plasma Separation Set; Rika Plasma Bottle 3/7/2022
BK210625 Bio-Rad Medical Diagnostics GmbH
Dreieich, Germany
IH-500 2/28/2022
BK210632 Royal Biologics, Inc.
Hackensack, NJ
Royal MAXX PRP Concentration System 2/11/2022
BK210591 Terumo BCT, Inc
Lakewood, CO
Platelet-Rich Plasma (PRP) Procedure Pack 2/11/2022
BK210652 Becton, Dickinson and Company
San Jose, CA
BD® Stem Cell Enumeration Kit 1/27/2022
BK210650 CSL Plasma
Knoxville, TN
LOGIC 4.0.8 1/25/2022
BK210649 Becton, Dickinson & Company
Franklin Lakes, NJ
BD Vacutainer ACD A Blood Collection Tube; BD Vacutainer ACD B Blood Collection Tube 1/21/2022


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