510(k) K083383 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Feb 18, 2009 |
| Received | Nov 17, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083383
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.