K121557 is an FDA 510(k) clearance for the WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST. This device is classified as a Enzyme Immunoassay, Cannabinoids (Class II - Special Controls, product code LDJ).
Submitted by Guangzhou Wondfo Biotech Co., Ltd. (Gaithersburg, US). The FDA issued a Cleared decision on July 25, 2012, 61 days after receiving the submission on May 25, 2012.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3870.
| 510(k) Number | K121557 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 25, 2012 |
| Decision Date | July 25, 2012 |
| Days to Decision | 61 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LDJ — Enzyme Immunoassay, Cannabinoids |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3870 |