
Ascensia Diabetes Care U.S., Inc.
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Contour Next EZ Blood Glucose Monitoring System is an FDA 510(k)-cleared medical device (K162336) 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 January 11, 2017. Regulation: 8.