Clearance Summary
Wondfo CR3 Keyless Split Sample Cup received FDA 510(k) clearance under submission number K151478, 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 2015-07-01.
- Submission: K151478
- 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: 2015-07-01
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.