510(k) K955100 ยท KLT Enzyme Immunoassay, Carbamazepine
CARBAMAZEPINE EIA TEST
| Applicant | Diagnostic Reagents, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Dec 13, 1995 |
| Received | Nov 8, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955100
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.