510(k) K200590 · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL)
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Apr 28, 2020 |
| Received | Mar 6, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200590
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.