510(k) K032936

DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR by Stanbio Laboratory — Product Code JIX

K032936 is an FDA 510(k) premarket notification submitted by Stanbio Laboratory for the device "DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR". The FDA issued a decision of Substantially Equivalent on March 12, 2004. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), a Class II device regulated under 21 CFR 862.1150. Stanbio Laboratory has at least 10 other 510(k) clearances on record.