510(k) K214002 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
CRYOcheck Chromogenic Factor IX
| Applicant | Precision Biologic, Inc., Darmouth, CA |
| Decision | Substantially Equivalent, Dec 23, 2022 |
| Received | Dec 21, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K214002
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.