510(k) K103627 ยท KLT Enzyme Immunoassay, Carbamazepine
ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Oct 14, 2011 |
| Received | Dec 13, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103627
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.