Clearance Summary
APO-Easy Genotyping kit received FDA 510(k) clearance under submission number DEN240032, sponsored by Firalis SA. The device was reviewed via the Direct premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2025-06-12.
- Submission: DEN240032
- Applicant / Sponsor: Firalis SA
- Clearance pathway: Direct
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5850
- Decision date: 2025-06-12
Classification & Regulation
This clearance is catalogued under FDA product code SFC and 21 CFR 866.5850, within the Immunology review panel as a Class II device.