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 |