U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Vaccines, Blood & Biologics
  3. Blood & Blood Products
  4. Approved Blood Products
  5. Substantially Equivalent 510(k) Device Information
  6. Cleared 510(k) Submissions with Supporting Documents - 2023
  1. Substantially Equivalent 510(k) Device Information

Cleared 510(k) Submissions with Supporting Documents - 2023

This list includes cleared 510(k) submissions for 2023 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
BK231015 MedMira Laboratories, Inc.
Canada		 Reveal® G4 Rapid HIV-1/2 Antibody Test 12/13/2023
BK231004 Buoy Software, LLC
Westport, CT		 Blood Product Questionnaire Module 11/16/2023
BK230986 MAK-SYSTEM Group Ltd.
London
United Kingdom		 ePROGESA v5.0.3 11/3/2023
BK230840 Roche Diagnostics
Indianapolis, IN		 Elecsys Anti-CMV; PreciControl Anti-CMV; PreciControl Release Anti-CMV 11/3/2023
BK230961 Beckman Coulter, Inc.
Miami, FL		 AQUIOS CL Flow Cytometer and AQUIOS Stem Kit 9/1/2023
BK230844 Biomet Biologics, Inc.
Warsaw, IN		 nSTRIDE® PRP Concentration System 8/9/2023
BK230971 Bio-Rad Medical Diagnostics GmbH
Redmond, WA		 IH-500 8/9/2023
BK230839 Roche Diagnostics
Indianapolis, IN		 Elecsys Syphilis; PreciControl Syphilis; PreciControl Release Syphilis 7/31/2023
BK230833 Beckman Coulter, Inc.
Chaska, MN		 Access HIV Ag/Ab combo; Access HIV Ag/Ab combo Calibrators; Access HIV Ag/Ab combo QC 7/27/2023
BK230843 Terumo BCT
Lakewood, CO		 Reveos® Automated Whole Blood Processing System 7/27/2023
BK230838 Terumo BCT
Lakewood, CO		 IMUGARD WB PLT Platelet Pooling Set 7/27/2023
BK230811 Diagnostic Grifols, S. A.
Barcelona, Spain		 Blood Typing Manager, version 3.0 7/24/2023
BK230835 Becton, Dickinson & Company
San Jose, CA		 BD Leucocount™ Kit; BD FACSuite™ Clinical BD Leucocount™ Assay Module; BD FACSLyric™ Flow Cytometer 7/24/2023
BK230826 WellSky Corporation
Overland Park, KS		 WellSky® Transfusion 2022 R3 7/19/2023
BK220791 GPI USA, Inc.
Houston, TX 		 e-Delphyn Donor 6/26/2023
BK230820 Diagnostic Grifols, S.A. 
Barcelona, Spain 		 Erytra Eflexis 6/22/2023
BK220798 Haemonetics Corporation
Boston, MA		 NexSys PCS® Plasma Collection System with Express®Plus Technology 6/20/2023
BK220668 Alma Lasers, Inc. VorFat System 6/12/2023
BK230818 YTS Global Inc.
Springfield, VA		 Dr. PRP 5/31/2023
BK230807 Genesis Biologics, Inc. Adaptive Autologous Processing System 5/10/2023
BK220779 Immucor, Inc.
Norcross, GA		 Capture Positive Control Cell 5/10/2023
BK230806 Immucor, Inc.
Norcross, GA		 ImmuLINK (v3.0) 4/25/2023
BK230824 Fresenius Kabi AG
Lake Zurich, IL		 AMICUS Separator System 4/21/2023
BK230804 Roche Diagnostics
Indianapolis, IN		 Elecsys HIV Duo 4/4/2023
BK220790 Blood Bank Computer Systems, Inc
Bonney Lake, WA		 Blood Bank Control System, Version 6.0 2/17/2023
BK220775 Hydra Srl
Italy		 Procedure Tray - Lipoaspirate fat harvest and injection kit 1/4/2023

 

Back to Top