K203489 is an FDA 510(k) clearance for the SEFRIA PCP Oral Fluid Enzyme Immunoassay. This device is classified as a Enzyme Immunoassay, Phencyclidine.
Submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on April 20, 2021, 144 days after receiving the submission on November 27, 2020.
This device falls under the Toxicology FDA review panel.
| 510(k) Number | K203489 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 27, 2020 |
| Decision Date | April 20, 2021 |
| Days to Decision | 144 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LCM — Enzyme Immunoassay, Phencyclidine |
| Device Class | — |