K904765 is an FDA 510(k) clearance for the EMIT (R) II PHENCYCLIDINE ASSAY. This device is classified as a Enzyme Immunoassay, Phencyclidine.
Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on November 28, 1990, 37 days after receiving the submission on October 22, 1990.
This device falls under the Toxicology FDA review panel.
| 510(k) Number | K904765 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 22, 1990 |
| Decision Date | November 28, 1990 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | LCM — Enzyme Immunoassay, Phencyclidine |
| Device Class | — |