510(k) K220803 · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Jan 27, 2023 |
| Received | Mar 18, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220803
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.