K242428 is an FDA 510(k) clearance for the Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus. This device is classified as a Test, Opiates, Over The Counter (Class II - Special Controls, product code NGL).
Submitted by Guangzhou Decheng Biotechnology Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on February 6, 2025, 175 days after receiving the submission on August 15, 2024.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3650.
| 510(k) Number | K242428 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 15, 2024 |
| Decision Date | February 06, 2025 |
| Days to Decision | 175 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | NGL - Test, Opiates, Over The Counter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3650 |