Submission Details
| 510(k) Number | K250067 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 10, 2025 |
| Decision Date | February 20, 2025 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
Dochek? Multi-Drug Urine Test Cup; Dochek? Multi-Drug Urine Test Cup Pro
Feb 2025
Decision
41d
Days
Class 2
Risk
About This 510(k) Submission
K250067 is an FDA 510(k) clearance for the Dochek? Multi-Drug Urine Test Cup; Dochek? Multi-Drug Urine Test Cup Pro, 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 20, 2025, 41 days after receiving the submission on January 10, 2025. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.
Device Classification
| Product Code | NGL — Test, Opiates, Over The Counter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3650 |
Manufacturer
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