Submission Details
| 510(k) Number | K142044 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE
Aug 2014
Decision
28d
Days
—
Risk
About This 510(k) Submission
K142044 is an FDA 510(k) clearance for the CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE, 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 review panel.
Device Classification
| Product Code | LCM — Enzyme Immunoassay, Phencyclidine |
| Device Class | — |
Manufacturer
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