510(k) K161216 ยท DJG Enzyme Immunoassay, Opiates
Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators
| Applicant | Immunalysis Corporation, Pomona CA, US |
| Decision | Substantially Equivalent, Jun 14, 2017 |
| Received | Apr 29, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161216
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.