510(k) K913863 ยท DJG Enzyme Immunoassay, Opiates
URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)
| Applicant | Immunalysis Corporation, Glendale CA, US |
| Decision | Substantially Equivalent, Sep 19, 1991 |
| Received | Aug 27, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913863
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.