Cleared Traditional

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

K242428 · Guangzhou Decheng Biotechnology Co., Ltd. · Toxicology
Feb 2025
Decision
175d
Days
Class 2
Risk

About This 510(k) Submission

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, 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 review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K242428 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code NGL — Test, Opiates, Over The Counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

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