
Beckman Coulter, Inc.
Free shipping on orders over $99 · 30-day returns
HDL CHOLESTEROL (HDLX) ASSAY is an FDA 510(k)-cleared medical device (K100010) manufactured by Beckman Coulter, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 13, 2010. Regulation: 8.