Cleared Traditional

Healgen? AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen? Immunofluorescence Analyzer (OG-H180)

K251972 · Healgen Scientific, LLC · Toxicology
Aug 2025
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K251972 is an FDA 510(k) clearance for the Healgen? AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen? Immunofluorescence Analyzer (OG-H180), a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Healgen Scientific, LLC (Houston, US). The FDA issued a Cleared decision on August 15, 2025, 50 days after receiving the submission on June 26, 2025. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K251972 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 2025
Decision Date August 15, 2025
Days to Decision 50 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DJG — Enzyme Immunoassay, Opiates
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

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