Cleared Traditional

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

K244043 · Hangzhou AllTest Biotech Co., Ltd. · Toxicology
Feb 2025
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K244043 is an FDA 510(k) clearance for the AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug 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 February 27, 2025, 59 days after receiving the submission on December 30, 2024. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K244043 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 2024
Decision Date February 27, 2025
Days to Decision 59 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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