K251972
- 510(k) number
- K251972
- Device name
- Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)
- Applicant
- Healgen Scientific,, LLC TX · US
- Product code
- DJG — Enzyme Immunoassay, Opiates
- Decision date
- 2025-08-15
- Date received
- 2025-06-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251972.pdf
Official FDA record: K251972
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.