Clearance Summary
Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer received FDA 510(k) clearance under submission number K214117, sponsored by Abbott Diagnostics Technologies AS. The device was reviewed via the Dual Track premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2023-09-27.
- Submission: K214117
- Applicant / Sponsor: Abbott Diagnostics Technologies AS
- Clearance pathway: Dual Track
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7470
- Decision date: 2023-09-27
Classification & Regulation
This clearance is catalogued under FDA product code LCP and 21 CFR 864.7470, within the Hematology review panel as a Class II device.