510(k) K053097 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
VITEK 2 GRAM POSITIVE CEFOXITIN SCREEN
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Dec 14, 2005 |
| Received | Nov 3, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053097
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 11, 2020 | Biomerieux Inc The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in-vitro test to determine susceptibility of Staphylococcus spp., Enterococcus Open, Classified |
N/A | None listed |
| Aug 30, 2018 | bioMerieux, Inc. bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Susceptibility Card
Cefotoxin and AST for Oxacillin
bioMerieux VITEK 2 AST-P631
Terminated |
LON | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.