Clearance Summary
GenaCheck COVID-19 Rapid Self-Test received FDA 510(k) clearance under submission number K251753, sponsored by Genabio Diagnostics, 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 2025-09-05.
- Submission: K251753
- Applicant / Sponsor: Genabio Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3984
- Decision date: 2025-09-05
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.