510(k) K223046 · NPR Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
Xpert® FII & FV
| Applicant | Cepheid®, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Feb 15, 2023 |
| Received | Sep 29, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K223046
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.