510(k) K832447 ยท KLT Enzyme Immunoassay, Carbamazepine
STRATUS CARBAMAZEPINE FLUROMETRIC
| Applicant | American Dade, Mchenry IL, US |
| Decision | Substantially Equivalent, Sep 12, 1983 |
| Received | Jul 25, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K832447
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.