510(k) K193204 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
Cryocheck Chromogenic Factor VIII
| Applicant | Precision Biologic, Darmouth, CA |
| Decision | Substantially Equivalent, Jul 17, 2020 |
| Received | Nov 20, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193204
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.