510(k) K080837 ยท NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
XPERT MRSA/SA SSTI ASSAY
| Applicant | Cepheid, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Sep 24, 2008 |
| Received | Mar 25, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080837
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.