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Pointe Scientific, Inc.,
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APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS is an FDA 510(k)-cleared medical device (K061377) manufactured by Pointe Scientific, Inc.,. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 27, 2007. Regulation: 8.