Cleared Traditional

AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup

K243996 · Assure Tech., LLC · Toxicology
Feb 2025
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K243996 is an FDA 510(k) clearance for the AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup, a Test, Amphetamine, Over The Counter (Class II — Special Controls, product code NFT), submitted by Assure Tech., LLC (Wilmington, US). The FDA issued a Cleared decision on February 7, 2025, 43 days after receiving the submission on December 26, 2024. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K243996 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 2024
Decision Date February 07, 2025
Days to Decision 43 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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