K122703 is an FDA 510(k) clearance for the RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTOR. This device is classified as a Enzyme Immunoassay, Phencyclidine.
Submitted by Biophor Diagnostics, Inc. (Redwood City, US). The FDA issued a Cleared decision on April 25, 2013, 233 days after receiving the submission on September 4, 2012.
This device falls under the Toxicology FDA review panel.
| 510(k) Number | K122703 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 2012 |
| Decision Date | April 25, 2013 |
| Days to Decision | 233 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LCM — Enzyme Immunoassay, Phencyclidine |
| Device Class | — |