K112071 is an FDA 510(k) clearance for the WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P. This device is classified as a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II - Special Controls, product code DIO).
Submitted by Guangzhou Wondfo Biotech Co., Ltd. (Gaithersburg, US). The FDA issued a Cleared decision on September 23, 2011, 65 days after receiving the submission on July 20, 2011.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3250.
| 510(k) Number | K112071 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 20, 2011 |
| Decision Date | September 23, 2011 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DIO — Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3250 |