510(k) K130894 ยท NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM; GENE
| Applicant | Cepheid, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jun 20, 2013 |
| Received | Apr 1, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130894
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.