Cleared Traditional

Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup

K243365 · Healgen Scientific, LLC · Toxicology
Dec 2024
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K243365 is an FDA 510(k) clearance for the Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup, a Test, Opiates, Over The Counter (Class II — Special Controls, product code NGL), submitted by Healgen Scientific, LLC (Houston, US). The FDA issued a Cleared decision on December 17, 2024, 49 days after receiving the submission on October 29, 2024. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K243365 FDA.gov
FDA Decision Cleared SESE
Date Received October 29, 2024
Decision Date December 17, 2024
Days to Decision 49 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code NGL — Test, Opiates, Over The Counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

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