Cleared Traditional

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

K241428 · Hangzhou AllTest Biotech Co., Ltd. · Toxicology
Jun 2024
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K241428 is an FDA 510(k) clearance for the AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid 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 June 17, 2024, 28 days after receiving the submission on May 20, 2024. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K241428 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 2024
Decision Date June 17, 2024
Days to Decision 28 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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