Cleared Traditional

AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup

K250727 · Hangzhou AllTest Biotech Co., Ltd. · Toxicology
Apr 2025
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K250727 is an FDA 510(k) clearance for the AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup, a Test, Amphetamine, Over The Counter (Class II — Special Controls, product code NFT), submitted by Hangzhou AllTest Biotech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on April 4, 2025, 24 days after receiving the submission on March 11, 2025. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K250727 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 2025
Decision Date April 04, 2025
Days to Decision 24 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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