510(k) K905211 ยท LLH Reagents, Clostridium Difficile Toxin
VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY
| Applicant | Vitek Systems, Inc., Rockland MA, US |
| Decision | Substantially Equivalent, Oct 11, 1991 |
| Received | Nov 20, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905211
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.