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 |
|---|---|---|---|
| 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 |