K152495 is an FDA 510(k) clearance for the Wondfo Propoxyphene Urine Test. This device is classified as a Enzyme Immunoassay, Propoxyphene (Class II - Special Controls, product code JXN).
Submitted by Guangzhou Wondfo Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on November 23, 2015, 83 days after receiving the submission on September 1, 2015.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3700.
| 510(k) Number | K152495 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 2015 |
| Decision Date | November 23, 2015 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | JXN — Enzyme Immunoassay, Propoxyphene |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3700 |