
Ascensia Diabetes Care
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CONTOUR® PLUS BLUE Blood Glucose Monitoring System is an FDA 510(k)-cleared medical device (K231679) 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 February 22, 2024. Regulation: 8.