K152176 is an FDA 510(k) clearance for the Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators. This device is classified as a Enzyme Immunoassay, Phencyclidine.
Submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on September 4, 2015, 31 days after receiving the submission on August 4, 2015.
This device falls under the Toxicology FDA review panel.
| 510(k) Number | K152176 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 2015 |
| Decision Date | September 04, 2015 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LCM — Enzyme Immunoassay, Phencyclidine |
| Device Class | — |