510(k) K234000 · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Mar 11, 2024 |
| Received | Dec 18, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K234000
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.