Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative +1 more— 510(k) K251972

Name: FDA 510(k) clearance K251972
Creator: U.S. Food and Drug Administration
Published: 2025-08-15

Substantially Equivalent

Healgen Scientific,, LLC

FDA 510(k) clearance K251972 for Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative +1 more, Substantially Equivalent on 2025-08-15. Applicant: Healgen Scientific,, LLC. Device class: 2.

Clearance details

Device name as filed: Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)
Applicant: Healgen Scientific,, LLC
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 2025-06-26
Decision date: 2025-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.