510(k) K802902 ยท KLT Enzyme Immunoassay, Carbamazepine
CYBREX CARBAMAZEPINE
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Dec 19, 1980 |
| Received | Nov 17, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K802902
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD Package Insert for TDx/TDxFLx and TDxFLx Carbamazepine Reagents, REF 9515, item number 69-5121/R4; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 Terminated |
KLT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.