510(k) K964068 ยท KLT Enzyme Immunoassay, Carbamazepine
CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
| Applicant | Bayer Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Dec 13, 1996 |
| Received | Oct 10, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964068
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.