510(k) K143500 ยท DKZ Enzyme Immunoassay, Amphetamine
Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set
| Applicant | Immunalysis Corporation, Pomona CA, US |
| Decision | Substantially Equivalent, Feb 6, 2015 |
| Received | Dec 10, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143500
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.