
Abbott Diabetes Care, Inc.
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THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS is an FDA 510(k)-cleared medical device (K070984) 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 October 31, 2007. Regulation: 8.