510(k) K964887 ยท LLH Reagents, Clostridium Difficile Toxin
VIDAS C. DIFFICILE TOXIN A II ASSAY
| Applicant | Biomerieux Vitek, Inc., Rockland MA, US |
| Decision | Substantially Equivalent, Apr 8, 1997 |
| Received | Dec 6, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964887
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.