510(k) K120911 ยท OQW 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV)
| Applicant | Cepheid, Sunnyvale CA, US |
| Decision | Substantially Equivalent, May 18, 2012 |
| Received | Mar 26, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120911
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.