510(k) K112937 ยท NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
MRSA/SA ELITE MGB
| Applicant | Elitech, Bothell WA, US |
| Decision | Substantially Equivalent, Jun 1, 2012 |
| Received | Oct 3, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112937
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.