Cleared Traditional

Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx

K202567 · Guangzhou Wondfo Biotech Co., Ltd. · Toxicology
Sep 2020
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K202567 is an FDA 510(k) clearance for the Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx, a Test, Amphetamine, Over The Counter (Class II — Special Controls, product code NFT), submitted by Guangzhou Wondfo Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on September 25, 2020, 21 days after receiving the submission on September 4, 2020. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K202567 FDA.gov
FDA Decision Cleared SESE
Date Received September 04, 2020
Decision Date September 25, 2020
Days to Decision 21 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code NFT — Test, Amphetamine, Over The Counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3100

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