510(k) K191766 · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Aug 5, 2019 |
| Received | Jul 1, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191766
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.