Clearance Summary
AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test received FDA 510(k) clearance under submission number K234006, sponsored by Allsource Screening Solutions. 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 2024-03-21.
- Submission: K234006
- Applicant / Sponsor: Allsource Screening Solutions
- Clearance pathway: Traditional
- Review panel: Clinical Toxicology
- Device class: Class II
- Regulation citation: 21 CFR 862.3650
- Decision date: 2024-03-21
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.