510(k) K854421 ยท DJG Enzyme Immunoassay, Opiates
TDX R OPIATES
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Nov 25, 1985 |
| Received | Nov 4, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854421
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.