510(k) K972619 ยท DJG Enzyme Immunoassay, Opiates
QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080)
| Applicant | Phamatech, Sandiego CA, US |
| Decision | Substantially Equivalent, Aug 20, 1997 |
| Received | Jul 11, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972619
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.