Class Class II

Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit – Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) (K251972)

K251972 2025-08-15 Traditional
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Description

Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) by Healgen Scientific, LLC — FDA 510(k) cleared clinical toxicology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK251972
Clearance Date2025-08-15
Clearance TypeTraditional
Product CodeDJG
Regulation Number862.3650

Categories

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