510(k) K230864 · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Jul 5, 2023 |
| Received | Mar 29, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230864
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.