Clearance Summary
Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) received FDA 510(k) clearance under submission number K241317, sponsored by Guangzhou Wondfo Biotech Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2024-09-30.
- Submission: K241317
- Applicant / Sponsor: Guangzhou Wondfo Biotech Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3984
- Decision date: 2024-09-30
Classification & Regulation
This clearance is catalogued under FDA product code QYT and 21 CFR 866.3984, within the Microbiology review panel as a Class II device.