K935191 is an FDA 510(k) clearance for the EMIT IIC PHENCYCLIDINE ASSAY. This device is classified as a Enzyme Immunoassay, Phencyclidine.
Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on February 22, 1995, 484 days after receiving the submission on October 26, 1993.
This device falls under the Toxicology FDA review panel.
| 510(k) Number | K935191 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 26, 1993 |
| Decision Date | February 22, 1995 |
| Days to Decision | 484 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LCM — Enzyme Immunoassay, Phencyclidine |
| Device Class | — |