510(k) K952096 ยท DJG Enzyme Immunoassay, Opiates
ONE STEP URINE DRUG OF ABUSE OPIATE TEST (OPIUM/HEROIN/MORPHINE)
| Applicant | Tcpi, Inc., Pompano Beach FL, US |
| Decision | Substantially Equivalent, Aug 17, 1995 |
| Received | May 4, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952096
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.