K142044 is an FDA 510(k) clearance for the CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE. This device is classified as a Enzyme Immunoassay, Phencyclidine.
Submitted by Guangzhou Wondfo Biotech Co., Ltd. (Gaithersburg, US). The FDA issued a Cleared decision on August 25, 2014, 28 days after receiving the submission on July 28, 2014.
This device falls under the Chemistry FDA review panel.
| 510(k) Number | K142044 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 2014 |
| Decision Date | August 25, 2014 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LCM — Enzyme Immunoassay, Phencyclidine |
| Device Class | — |