510(k) K972405 ยท DJG Enzyme Immunoassay, Opiates
QUIKPAC II ONE STEP OPIATE TEST
| Applicant | Drial Consultants, Inc., Simi Valley CA, US |
| Decision | Substantially Equivalent, Aug 8, 1997 |
| Received | Jun 26, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972405
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.