510(k) K183524 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Mar 12, 2019 |
| Received | Dec 19, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183524
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.