510(k) K213931 · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Jun 3, 2022 |
| Received | Dec 16, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213931
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.