Clearance Summary
Alere Afinion HbA1c and ACR on Afinion 2 analyzer received FDA 510(k) clearance under submission number K171650, sponsored by Abbott Rapid Diagnostics. The device was reviewed via the Special premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2017-11-21.
- Submission: K171650
- Applicant / Sponsor: Abbott Rapid Diagnostics
- Clearance pathway: Special
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7470
- Decision date: 2017-11-21
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.