510(k) K143502 ยท DJG Enzyme Immunoassay, Opiates
Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls
| Applicant | Immunalysis Corporation, Pomona CA, US |
| Decision | Substantially Equivalent, May 20, 2015 |
| Received | Dec 10, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143502
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.