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U.S. Food and Drug Administration
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  5. Substantially Equivalent 510(k) Device Information
  6. 510(k) Blood Establishment Computer Software - 2023
  1. Substantially Equivalent 510(k) Device Information

510(k) Blood Establishment Computer Software - 2023

Software is listed by clearance date in reverse chronological order.

510(k) Number Applicant Device Name Decision Date
BK231004 Buoy Software, LLC
55 Post Road West, 2nd Floor
Westport, CT 06880		 Blood Product Questionnaire Module 11/16/2023
BK230986 MAK-SYSTEM Group Ltd.
1 Bartholomew Lane
EC2N 2AX London, UK		 ePROGESA v5.0.3 11/3/2023
BK230811 Diagnostic Grifols, S. A.
Passeig Fluvial, 24
Parets del Valles, Barcelona 08150
Spain		 Blood Typing Manager, version 3.0 7/24/2023
BK230826 WellSky Corporation
11300 Switzer Road
Overland Park, KS 66210		 WellSky® Transfusion 2022 R3 7/19/2023
BK220791 GPI USA, Inc.
4900 Woodway Drive, Suite 680
Houston, TX 77056		 e-Delphyn Donor 6/26/2023
BK230806 Immucor, Inc.
3130 Gateway Drive
Norcross, GA 30071		 ImmuLINK (v3.0) 4/25/2023
BK220790 Blood Bank Computer Systems, Inc
7206 Vandermark Road, East
Bonney Lake, WA 98391		 Blood Bank Control System, Version 6.0 2/17/2023

 

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