Clearance Summary
WELLlife COVID-19 / Influenza A&B Home Test; WELLlife COVID-19 / Influenza A&B AntigenTest received FDA 510(k) clearance under submission number K243256, sponsored by Wondfo USA 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 2025-01-16.
- Submission: K243256
- Applicant / Sponsor: Wondfo USA Co, Ltd.
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3987
- Decision date: 2025-01-16
Classification & Regulation
This clearance is catalogued under FDA product code SCA and 21 CFR 866.3987, within the Microbiology review panel as a Class II device.