
Stanbio Laboratory
Free shipping on orders over $99 · 30-day returns
DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR is an FDA 510(k)-cleared medical device (K032936) manufactured by Stanbio Laboratory. 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 March 11, 2004. Regulation: 8.