Clearance Summary
Nano-Check Influenza A+B Test received FDA 510(k) clearance under submission number K252283, sponsored by Nano-Ditech Corporation. 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 2026-01-15.
- Submission: K252283
- Applicant / Sponsor: Nano-Ditech Corporation
- Clearance pathway: Dual Track
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3328
- Decision date: 2026-01-15
Classification & Regulation
This clearance is catalogued under FDA product code PSZ and 21 CFR 866.3328, within the Microbiology review panel as a Class II device.