Cleared Traditional

Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup

K252554 · Vivachek Biotech (Hangzhou) Co., Ltd. · Toxicology
Sep 2025
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K252554 is an FDA 510(k) clearance for the Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup, a Test, Amphetamine, Over The Counter (Class II — Special Controls, product code NFT), submitted by Vivachek Biotech (Hangzhou) Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on September 12, 2025, 30 days after receiving the submission on August 13, 2025. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K252554 FDA.gov
FDA Decision Cleared SESE
Date Received August 13, 2025
Decision Date September 12, 2025
Days to Decision 30 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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