510(k) K053186 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
VITEK 2 GRAM POSITIVE TELITHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Dec 1, 2005 |
| Received | Nov 14, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053186
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.