510(k) K063131 ยท KLT Enzyme Immunoassay, Carbamazepine
CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS
| Applicant | Thermo Electron OY, Vantaa, FI |
| Decision | Substantially Equivalent, Oct 5, 2007 |
| Received | Oct 13, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063131
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.