510(k) K031902 ยท KLT Enzyme Immunoassay, Carbamazepine
ONLINE TDM CARBAMAZEPINE
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Sep 17, 2003 |
| Received | Jun 20, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031902
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.