510(k) K260281 · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)
| Applicant | BIOMERIEUX, Hazelwood MO, US |
| Decision | Substantially Equivalent, Mar 26, 2026 |
| Received | Jan 29, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260281
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.