510(k) K001178 ยท DJG Enzyme Immunoassay, Opiates
CEDIA DAU 6-ACETYLMORPHINE ASSAY
| Applicant | Microgenics Corp., Fremont Blvd. CA, US |
| Decision | Substantially Equivalent, Jun 9, 2000 |
| Received | Apr 11, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001178
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.