510(k) Blood Establishment Computer Software - 2024
Software is listed by clearance date in reverse chronological order.
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| BK241081 | Epic Systems Corporation 1979 Milky Way Verona, WI 53593 |
Blood Product Administration Module (BPAM 4-2023) | 8/21/2024 |
| BK241080 | Immucor, Inc. 3130 Gateway Drive Norcross, GA 30071 |
ImmuLINK (v3.2) | 8/6/2024 |
| BK241069 | Carter BloodCare 2205 Highway 121 South Bedford, TX 76021 |
Blood Bank Information Management System (BBIMS) v3.01 | 7/9/2024 |
| BK241062 | Haemonetics Corporation 125 Summer Street Boston, MA 02110 |
BloodTrack Software 4.16.0 | 6/21/2024 |
| BK230958 | eDonorSoft, LLC 1619 Whitfield Street Sugarland, TX 77479 |
HemDonER 1.0.1 | 5/31/2024 |
| BK230814 | Life Plasma, Inc. 5438 Perkiomen Avenue Reading, PA 19606 |
SmartDMS | 4/16/2024 |
| BK231036 | Haemonetics Corporation 125 Summer Street Boston, MA 02110 |
NexLynk DMS® Donor Management System 4.10.0 | 3/15/2024 |