510(k) K191742 ยท NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
ARIES MRSA Assay
| Applicant | Luminex Corporation, Austin TX, US |
| Decision | Substantially Equivalent, Sep 25, 2019 |
| Received | Jul 1, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191742
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.