Clearance Summary
Acucy® Influenza A&B Test with the Acucy® 2 System received FDA 510(k) clearance under submission number K241188, sponsored by SEKISUI Diagnostics, LLC. 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 2025-04-18.
- Submission: K241188
- Applicant / Sponsor: SEKISUI Diagnostics, LLC
- Clearance pathway: Dual Track
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3328
- Decision date: 2025-04-18
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.