510(k) K132468 ยท NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
MRSA/SA ELITE MGB, ELITE MGB SOFTWARE
| Applicant | Elitechgroup Epoch Biosciences, Bothell WA, US |
| Decision | Substantially Equivalent, Oct 17, 2013 |
| Received | Aug 7, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132468
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.