Cleared Traditional

Dochek? Multi-Drug Urine Test Cup Rx, Dochek? Multi-Drug Urine Test Cup

K232659 · Guangzhou Decheng Biotechnology Co., Ltd. · Toxicology
Dec 2023
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K232659 is an FDA 510(k) clearance for the Dochek? Multi-Drug Urine Test Cup Rx, Dochek? Multi-Drug Urine Test Cup, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Guangzhou Decheng Biotechnology Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on December 13, 2023, 104 days after receiving the submission on August 31, 2023. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K232659 FDA.gov
FDA Decision Cleared SESE
Date Received August 31, 2023
Decision Date December 13, 2023
Days to Decision 104 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DJG — Enzyme Immunoassay, Opiates
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

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