
Abbott Diabetes Care, Inc.
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FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23 is an FDA 510(k)-cleared medical device (K092638) 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 June 14, 2010. Regulation: 8.