K874626 is an FDA 510(k) clearance for the REVISED LABELING FOR SYVA PHENCYCLIDINE ASSAYS. This device is classified as a Radioimmunoassay, Phencyclidine.
Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on January 11, 1988, 62 days after receiving the submission on November 10, 1987.
This device falls under the Toxicology FDA review panel.
| 510(k) Number | K874626 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 10, 1987 |
| Decision Date | January 11, 1988 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | LCL — Radioimmunoassay, Phencyclidine |
| Device Class | — |