510(k) K092953 ยท NIJ System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
Xpert VanA Assay
| Applicant | Cepheid, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Dec 17, 2009 |
| Received | Sep 24, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092953
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.