Clearance Summary
Alere Afinion HbA1c, Alere Afinion AS100 Analyzer received FDA 510(k) clearance under submission number K151809, sponsored by Alere Technologies AS. The device was reviewed via the Special premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2015-09-25.
- Submission: K151809
- Applicant / Sponsor: Alere Technologies AS
- Clearance pathway: Special
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7470
- Decision date: 2015-09-25
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.