510(k) K163101 ยท DJG Enzyme Immunoassay, Opiates
CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control Set
| Applicant | Microgenics Corporation, Fremont CA, US |
| Decision | Substantially Equivalent, Apr 6, 2017 |
| Received | Nov 7, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163101
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.