Clearance Summary
Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard received FDA 510(k) clearance under submission number K153050, sponsored by Co-Innovation 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 2016-04-26.
- Submission: K153050
- Applicant / Sponsor: Co-Innovation Biotech Co., Ltd.
- Clearance pathway: Special
- Review panel: Clinical Toxicology
- Device class: Class II
- Regulation citation: 21 CFR 862.3650
- Decision date: 2016-04-26
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.