510(k) K223478 · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Feb 16, 2023 |
| Received | Nov 18, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223478
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.