510(k) K151578 ยท KLT Enzyme Immunoassay, Carbamazepine
Carbamazepine Gen 4
| Applicant | Roche Diagnostics Operations (Rdo), Indianapolis IN, US |
| Decision | Substantially Equivalent, Oct 22, 2015 |
| Received | Jun 11, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151578
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.