510(k) K210287 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Oct 28, 2021 |
| Received | Feb 2, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210287
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.