510(k) K163563 · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
VITEK 2 AST-GN Gentamicin (<=1 >=16 µg/mL)
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Mar 13, 2017 |
| Received | Dec 19, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163563
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.