510(k) K042963 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR ERTAPENEM
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Dec 13, 2004 |
| Received | Oct 27, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042963
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.