Clearance Summary
AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup received FDA 510(k) clearance under submission number K243996, sponsored by Assure Tech., 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 2025-02-07.
- Submission: K243996
- Applicant / Sponsor: Assure Tech., LLC
- Clearance pathway: Traditional
- Review panel: Clinical Toxicology
- Device class: Class II
- Regulation citation: 21 CFR 862.3100
- Decision date: 2025-02-07
Classification & Regulation
This clearance is catalogued under FDA product code NFT and 21 CFR 862.3100, within the Clinical Toxicology review panel as a Class II device.