510(k) K964765 ยท KLT Enzyme Immunoassay, Carbamazepine
CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY
| Applicant | Chiron Diagnostics Corp., Medfield MA, US |
| Decision | Substantially Equivalent, Feb 14, 1997 |
| Received | Nov 27, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964765
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.