510(k) K123518 ยท KLT Enzyme Immunoassay, Carbamazepine
ABBOTT CARBAMAZEPINE ASSAY
| Applicant | Microgenics Corporation, Fremont Blvd. CA, US |
| Decision | Substantially Equivalent, Jun 5, 2013 |
| Received | Nov 14, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123518
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.