510(k) K210687

CONTOUR® NEXT ONE Blood Glucose Monitoring System by Ascensia Diabetes Care — Product Code NBW

K210687 is an FDA 510(k) premarket notification submitted by Ascensia Diabetes Care for the device "CONTOUR® NEXT ONE Blood Glucose Monitoring System". The FDA issued a decision of Substantially Equivalent on August 11, 2021. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Ascensia Diabetes Care has at least 4 other 510(k) clearances on record.