Clearance Summary
AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx received FDA 510(k) clearance under submission number K233019, sponsored by Hangzhou AllTest Biotech Co., Ltd.. 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 2023-12-13.
- Submission: K233019
- Applicant / Sponsor: Hangzhou AllTest Biotech Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Toxicology
- Device class: Class II
- Regulation citation: 21 CFR 862.3100
- Decision date: 2023-12-13
Classification & Regulation
This clearance is catalogued under FDA product code DKZ and 21 CFR 862.3100, within the Clinical Toxicology review panel as a Class II device.