510(k) K063623 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
VITEK 2 GRAM POSITIVE MEROPENEM FOR STREPTOCOCCUS PNEUMONIAE
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Jan 11, 2007 |
| Received | Dec 6, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063623
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.