Clearance Summary
Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC received FDA 510(k) clearance under submission number K242498, sponsored by Aicheck Biotech, Inc.. 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 2024-10-01.
- Submission: K242498
- Applicant / Sponsor: Aicheck Biotech, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Toxicology
- Device class: Class II
- Regulation citation: 21 CFR 862.3100
- Decision date: 2024-10-01
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.