Clearance Summary
WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P received FDA 510(k) clearance under submission number K112071, sponsored by Guangzhou Wondfo 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 2011-09-23.
- Submission: K112071
- Applicant / Sponsor: Guangzhou Wondfo Biotech Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Toxicology
- Device class: Class II
- Regulation citation: 21 CFR 862.3250
- Decision date: 2011-09-23
Classification & Regulation
This clearance is catalogued under FDA product code DIO and 21 CFR 862.3250, within the Clinical Toxicology review panel as a Class II device.