K790401 is an FDA 510(k) clearance for the PHENCYCLIDINE URINE ASSAY. This device is classified as a Enzyme Immunoassay, Phencyclidine.
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on June 15, 1979, 109 days after receiving the submission on February 26, 1979.
This device falls under the Toxicology FDA review panel.
| 510(k) Number | K790401 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 1979 |
| Decision Date | June 15, 1979 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | LCM — Enzyme Immunoassay, Phencyclidine |
| Device Class | — |