510(k) K152075 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL)
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Apr 15, 2016 |
| Received | Jul 27, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152075
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2023 | Biomerieux Inc VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829 Open, Classified |
LON | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.