510(k) K964864 ยท LLH Reagents, Clostridium Difficile Toxin
PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY
| Applicant | Alexon Biomedical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Feb 4, 1997 |
| Received | Dec 4, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964864
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.