Cleared 510(k) Submissions with Supporting Documents - 2023
This list includes cleared 510(k) submissions for 2023 for which we have supporting documents available, and reflects the information as of the clearance date. It is not updated with regard to applicant or application status change.
The clearances are listed by clearance date in reverse chronological order.
510(k) Number | Applicant | Device Name | Decision Date |
---|---|---|---|
BK230807 | Genesis Biologics, Inc. | Adaptive Autologous Processing System | 5/10/2023 |
BK220779 | Immucor, Inc. Norcross, GA |
Capture Positive Control Cell | 5/10/2023 |
BK230806 | Immucor, Inc. Norcross, GA |
ImmuLINK (v3.0) | 4/25/2023 |
BK230824 | Fresenius Kabi AG Lake Zurich, IL |
AMICUS Separator System | 4/21/2023 |
BK230804 | Roche Diagnostics Indianapolis, IN |
Elecsys HIV Duo | 4/4/2023 |
BK220790 | Blood Bank Computer Systems, Inc Bonney Lake, WA |
Blood Bank Control System, Version 6.0 | 2/17/2023 |
BK220775 | Hydra Srl Italy |
Procedure Tray - Lipoaspirate fat harvest and injection kit | 1/4/2023 |