510(k) K121100 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
VITEK 2 AST STREPTOCOCUS VANCOMYCIN
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Nov 19, 2012 |
| Received | Apr 11, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121100
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2023 | Biomerieux Inc VITEK 2 REAGENT AST-ST02 TEST KIT 20 CARDS, CATALOG 420915 Open, Classified |
LON | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.