Clearance Summary
SAFElife Fentanyl Urine Home Test (Cassette); SAFElife Fentanyl (FTY) Urine Test Cassette; SAFElife T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife T-Dip Fentanyl (FTY) Urine Test Panel received FDA 510(k) clearance under submission number K241741, 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 2024-07-16.
- Submission: K241741
- Applicant / Sponsor: Guangzhou Wondfo Biotech Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Toxicology
- Device class: Class II
- Regulation citation: 21 CFR 862.3650
- Decision date: 2024-07-16
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.