Clearance Summary
WONDOFO MULTI-DRUG URINE TEST CUP / PANEL received FDA 510(k) clearance under submission number K130665, sponsored by Guangzhou Wondfo Biotech Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Toxicology review panel. The statutory decision date of record is 2013-04-09.
- Submission: K130665
- Applicant / Sponsor: Guangzhou Wondfo Biotech Co., Ltd.
- Clearance pathway: Special
- Review panel: Clinical Toxicology
- Device class: Class II
- Regulation citation: 21 CFR 862.3650
- Decision date: 2013-04-09
Classification & Regulation
This clearance is catalogued under FDA product code DJG and 21 CFR 862.3650, within the Clinical Toxicology review panel as a Class II device.