510(k) K080931 ยท LLH Reagents, Clostridium Difficile Toxin
VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Jun 11, 2008 |
| Received | Apr 2, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080931
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.