510(k) Blood Establishment Computer Software - 2025
Software is listed by clearance date in reverse chronological order.
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| BK251256 | Immucor, Inc. 3130 Gateway Drive Norcross, GA 30071 | ImmuLINK (v3.3) | 10/24/2025 |
| BK251241 | Haemonetics Corporation 125 Summer Street Boston, MA 02110 | SafeTrace Tx® Software 5.0.0 | 9/10/2025 |
| BK251188 | MAK-SYSTEM Group Ltd. 1 Bartholomew Lane EC2N 2AX London United Kingdom | Patient Health Software (P.H.S) v11.0.0.0 | 6/11/2025 |
| BK241136 | BioLife Plasma Services LP 1200 Lakeside Drive Bannockburn, IL 60015 | Lookback Notification System version 2.0 | 2/20/2025 |