Cleared Traditional

AssureTech Panel Dip Tests, AssureTech Quick Cup Tests

K181768 · Assure Tech. (Hangzhou) Co, Ltd. · Toxicology
Aug 2018
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K181768 is an FDA 510(k) clearance for the AssureTech Panel Dip Tests, AssureTech Quick Cup Tests, a Test, Amphetamine, Over The Counter (Class II — Special Controls, product code NFT), submitted by Assure Tech. (Hangzhou) Co, Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on August 20, 2018, 48 days after receiving the submission on July 3, 2018. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K181768 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 2018
Decision Date August 20, 2018
Days to Decision 48 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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