Device Listing 1956609105
Listing Summary#
- Listing key
- 1956609105
- Premarket submission
- K251972
- Device
- Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)
- Applicant
- Healgen Scientific,, LLC
- Product code
- DJG
- Decision date
- 2025-08-15