510(k) K040471

OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296; OLYMPUS LDL CHOLESTEROL CALIBRATOR, ODC0024 by Olympus America, Inc. — Product Code JIT

K040471 is an FDA 510(k) premarket notification submitted by Olympus America, Inc. for the device "OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296; OLYMPUS LDL CHOLESTEROL CALIBRATOR, ODC0024". The FDA issued a decision of Substantially Equivalent on March 10, 2004. The device falls under product code JIT (Calibrator, Secondary), a Class II device regulated under 21 CFR 862.1150. Olympus America, Inc. has at least 10 other 510(k) clearances on record.