510(k) K260619 · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
VITEK 2 AST-Streptococcus Cefepime (<=0.06 >=4 µg/mL)
| Applicant | Biomérieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Sep 28, 2026 |
| Received | Feb 25, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260619
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.