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  6. Cleared 510(k) Submissions with Supporting Documents - 2024
  1. Substantially Equivalent 510(k) Device Information

Cleared 510(k) Submissions with Supporting Documents - 2024

This list includes cleared 510(k) submissions for 2024 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
BK241083 OrthoAscent
Ashland, MA		 Platelet And Plasma Separator For Bone Graft Handling 9/26/2024
BK241042 Gale Force Aesthetics, LLC
Alamo, CA		 Illuminate PRP 8/27/2024
BK241081 Epic Systems Corporation
Verona, WI		 Blood Product Administration Module (BPAM 4-2023) 8/21/2024
BK241080 Immucor, Inc.
Norcross, GA		 ImmuLINK (v3.2) 8/6/2024
BK231025 Hologic, Inc.
San Diego, CA		 Aptima® HIV-1 Quant Dx Assay 8/6/2024
BK241074 One Lambda, Inc.
West Hills, CA		 SeCore CDx HLA Sequencing System 8/1/2024
BK241069 Carter BloodCare
Bedford, TX		 Blood Bank Information Management System (BBIMS) v3.01 7/9/2024
BK241062 Haemonetics Corporation
Boston, MA		 BloodTrack Software 4.16.0 6/21/2024
BK231031 NanoEntek, Inc.
Korea		 ADAMII CD34 System 6/5/2024
BK230958 eDonorSoft, LLC
Sugarland, TX		 HemDonER 1.0.1 5/31/2024
BK231013 Musculoskeletal Transplant Foundation (MTF Biologics)
Edison, NJ		 LipoGrafter® Kit 5/16/2024
BK241060 Arthrex, Inc.
Naples, FL		 Arthrex Thrombinator System 4/24/2024
BK230980 Becton, Dickinson & Company
Franklin Lakes, NJ		 BD Vacutainer® K2EDTA Blood Collection Tubes 4/17/2024
BK230814 Life Plasma, Inc.
Reading, PA		 SmartDMS 4/16/2024
BK230825 Fresenius Kabi AG
Lake Zurich, IL		 ALYX 2RBC-LR Kit 4/5/2024
BK230968 Reapplix ApS 3C OrthoPatch Device 3/29/2024
BK231036 Haemonetics Corporation
Boston, MA		 NexLynk DMS® Donor Management System 4.10.0 03/15/2024
BK231035 Terumo BCT
Lakewood, CO		 Rika Plasma Donation System (V2.1) 03/07/2024
BK231016 Aeon Biotherapeutics Corp.
Taiwan		 Aeon ACKit 02/16/2024
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