Clearance Summary
Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx received FDA 510(k) clearance under submission number K222667, sponsored by Vivachek Biotech (Hangzhou) 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 2022-11-10.
- Submission: K222667
- Applicant / Sponsor: Vivachek Biotech (Hangzhou) Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Toxicology
- Device class: Class II
- Regulation citation: 21 CFR 862.3100
- Decision date: 2022-11-10
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.