510(k) K222831 ยท GJT Plasma, Coagulation Factor Deficient
CRYOcheck Factor VIII Deficient Plasma with VWF
| Applicant | Precision Biologic, Inc., Darmouth, CA |
| Decision | Substantially Equivalent, Sep 13, 2023 |
| Received | Sep 19, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222831
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.