510(k) K161714 ยท DIS Enzyme Immunoassay, Barbiturate
Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
| Applicant | Immunalysis Corporation, Pomona CA, US |
| Decision | Substantially Equivalent, Oct 14, 2016 |
| Received | Jun 21, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161714
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.