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Polymedco, Inc.
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POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC is an FDA 510(k)-cleared medical device (K100550) manufactured by Polymedco, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on September 27, 2010. Regulation: 8.