Clearance Summary
Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine) received FDA 510(k) clearance under submission number K240949, sponsored by Healgen Scientific,, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Toxicology review panel. The statutory decision date of record is 2024-05-13.
- Submission: K240949
- Applicant / Sponsor: Healgen Scientific,, LLC
- Clearance pathway: Traditional
- Review panel: Clinical Toxicology
- Device class: Class II
- Regulation citation: 21 CFR 862.3650
- Decision date: 2024-05-13
Classification & Regulation
This clearance is catalogued under FDA product code NGL and 21 CFR 862.3650, within the Clinical Toxicology review panel as a Class II device.