510(k) K243625 · NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Xpert MRSA/SA SSTI
| Applicant | Cepheid®, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Dec 18, 2024 |
| Received | Nov 25, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K243625
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.