510(k) K040845 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
VITEK 2 ESBL TEST
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Jun 8, 2004 |
| Received | Apr 1, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040845
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2023 | Biomerieux Inc VITEK 2 REAGENT AST-GN69 TEST KIT 20 CARDS, CATALOG 413400 Open, Classified |
LON | None listed |
| Jan 4, 2023 | Biomerieux Inc VITEK 2 REAGENT AST-GN80 TEST KIT 20 CARDS, CATALOG 413437 Open, Classified |
LON | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.