510(k) K260160 ยท SAN Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Jul 8, 2026 |
| Received | Jan 20, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260160
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.