Clearance Summary
BinaxNOW COVID-19 Ag Card received FDA 510(k) clearance under submission number K250273, sponsored by Abbott Diagnostics Scarborough, Inc.. The device was reviewed via the Dual Track premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2025-06-13.
- Submission: K250273
- Applicant / Sponsor: Abbott Diagnostics Scarborough, Inc.
- Clearance pathway: Dual Track
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3982
- Decision date: 2025-06-13
Classification & Regulation
This clearance is catalogued under FDA product code QVF and 21 CFR 866.3982, within the Microbiology review panel as a Class II device.