510(k) K171650

Alere Afinion HbA1c and ACR on Afinion 2 analyzer by Abbott Rapid Diagnostics — Product Code LCP

K171650 is an FDA 510(k) premarket notification submitted by Abbott Rapid Diagnostics for the device "Alere Afinion HbA1c and ACR on Afinion 2 analyzer". The FDA issued a decision of Substantially Equivalent on November 21, 2017. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470.