510(k) K251972

Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) by Healgen Scientific,, LLC — Product Code DJG

K251972 is an FDA 510(k) premarket notification submitted by Healgen Scientific,, LLC for the device "Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)". The FDA issued a decision of Substantially Equivalent on August 15, 2025. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Healgen Scientific,, LLC has at least 10 other 510(k) clearances on record.