510(k) K243405 · NIJ System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
Xpert vanA
| Applicant | Cepheid®, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Nov 21, 2024 |
| Received | Nov 1, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K243405
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.