510(k) K222430 · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin
| Applicant | Biomerieux Sa, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Mar 9, 2023 |
| Received | Aug 11, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222430
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.