Alere Afinion HbA1c and ACR on Afinion 2 analyzer

Alere Afinion HbA1c and ACR on Afinion 2 analyzer is an FDA 510(k)-cleared medical device (K171650) manufactured by Abbott Rapid Diagnostics. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 20, 2017. Regulation: 8.