Clearance Summary
BinaxNOW COVID-19 Antigen Self Test received FDA 510(k) clearance under submission number K243518, sponsored by Abbott Diagnostics Scarborough, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2025-02-11.
- Submission: K243518
- Applicant / Sponsor: Abbott Diagnostics Scarborough, Inc.
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3984
- Decision date: 2025-02-11
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.