Cleared Traditional

Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card

K253567 · Healgen Scientific, LLC · Toxicology
Dec 2025
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K253567 is an FDA 510(k) clearance for the Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card, 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 23, 2025, 36 days after receiving the submission on November 17, 2025. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K253567 FDA.gov
FDA Decision Cleared SESE
Date Received November 17, 2025
Decision Date December 23, 2025
Days to Decision 36 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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