
Ascensia Diabetes Care
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Contour® next GEN Blood Glucose Monitoring System is an FDA 510(k)-cleared medical device (K193407) manufactured by Ascensia Diabetes Care. 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 December 22, 2021. Regulation: 8.