HYDRAGEL 7,15,30, CHOL-HDL KIT

HYDRAGEL 7,15,30, CHOL-HDL KIT is an FDA 510(k)-cleared medical device (K972015) manufactured by Morax. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 26, 1997. Regulation: 8.