510(k) K040316 ยท DJG Enzyme Immunoassay, Opiates
CEDIA BUPRENORPHINE ASSAY
| Applicant | Microgenics Corp., Fremont Blvd. CA, US |
| Decision | Substantially Equivalent, Jun 23, 2004 |
| Received | Feb 9, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040316
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.