
Abbott Diabetes Care, Inc.
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FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) is an FDA 510(k)-cleared medical device (K210943) manufactured by Abbott Diabetes Care, 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 November 21, 2021. Regulation: 8.