510(k) K260282 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Apr 15, 2026 |
| Received | Jan 29, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260282
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.