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Abbott Diabetes Care, Inc.
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PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS is an FDA 510(k)-cleared medical device (K060768) manufactured by Abbott Diabetes Care, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 20, 2006. Regulation: 8.