510(k) K212849 · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
VITEK 2 AST-Gram Positive Linezolid (<=0.5 >=8 µg/mL)
| Applicant | Biomérieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Feb 4, 2022 |
| Received | Sep 7, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K212849
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.