510(k) K151395 ยท DJR Enzyme Immunoassay, Methadone
Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets
| Applicant | Immunalysis Corporation, Pomona CA, US |
| Decision | Substantially Equivalent, Jul 24, 2015 |
| Received | May 26, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151395
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 28, 2017 | Alere San Diego Inc. DBA Immunalysis Corporation lmmunalysis EDDP Urine Control Set 1
The EDDP Urine Controls (High 125 ng/ml and Low 75 ng/ml) are used as control materials in the ammonolysis EDDP Specific Urine Enzyme Immunoassay, which has a cut Terminated |
DJR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.