Clearance Summary
Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard received FDA 510(k) clearance under submission number K241100, sponsored by Co-Innovation 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 2024-05-22.
- Submission: K241100
- Applicant / Sponsor: Co-Innovation Biotech Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Toxicology
- Device class: Class II
- Regulation citation: 21 CFR 862.3650
- Decision date: 2024-05-22
Classification & Regulation
This clearance is catalogued under FDA product code NGL and 21 CFR 862.3650, within the Clinical Toxicology review panel as a Class II device.