510(k) K043230 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR ERTAPENEM
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Dec 30, 2004 |
| Received | Nov 22, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043230
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.