LIQUISPX HDL/LDL LIQUID CHOLESTEROL CALIBRATOR

LIQUISPX HDL/LDL LIQUID CHOLESTEROL CALIBRATOR is an FDA 510(k)-cleared medical device (K010030) manufactured by Synergent Biochem Inc.-Clinical Controls Div.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 13, 2001. Regulation: 8.