510(k) K874485 ยท DJG Enzyme Immunoassay, Opiates
REVISED LABELING FOR OPIATES
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Nov 23, 1987 |
| Received | Oct 30, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K874485
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 28, 2004 | Abbott Health Products, Inc. TDx/TDxFLx Opiates Reagent, Product list number: 9673-60 Terminated |
DJG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.