Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System

Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System is an FDA 510(k)-cleared medical device (K160430) manufactured by Ascensia Diabetes Care U.S., Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 23, 2016. Regulation: 8.