Cleared Traditional

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

K242540 · Hangzhou AllTest Biotech Co., Ltd. · Toxicology
Sep 2024
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K242540 is an FDA 510(k) clearance for the AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel, 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 September 27, 2024, 32 days after receiving the submission on August 26, 2024. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K242540 FDA.gov
FDA Decision Cleared SESE
Date Received August 26, 2024
Decision Date September 27, 2024
Days to Decision 32 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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