510(k) K912365 ยท JXN Enzyme Immunoassay, Propoxyphene
TDX(R)/TDXFLX(TM) & ADX(R) PROPOXPHENE ASSAYS
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Aug 16, 1991 |
| Received | May 29, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912365
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.