510(k) K821945 ยท KLT Enzyme Immunoassay, Carbamazepine
CARBAMAZEPINE FLOURESCENT IMMUNOASSAY
| Applicant | American Diagnostic Corp., Mchenry IL, US |
| Decision | Substantially Equivalent, Jul 16, 1982 |
| Received | Jun 29, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K821945
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.