Precision Biologic, Inc.
FDA 510(k) & PMA Approved Devices — 4 products
Total Devices4
Categories2
Latest FDA decision2025-08-25
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K251440 | CRYOcheck Chromogenic Factor VIII | GGP | 2025-08-25 | View |
| 510(k) | K222831 | CRYOcheck Factor VIII Deficient Plasma with VWF | GJT | 2023-09-13 | View |
| 510(k) | K214002 | CRYOcheck Chromogenic Factor IX | GGP | 2022-12-23 | View |
| 510(k) | K183440 | CRYOcheck FVIII Inhibitor Kit | GGP | 2019-03-12 | View |
No matching devices.