510(k) K040692

OLYMPUS HDL CHOLESTEROL REAGENT, OSR6195/OSR6295 AND OLYMPUS HDL CHOLESTEROL CALIBRATOR ODC0023 by Olympus America, Inc. — Product Code JIT

K040692 is an FDA 510(k) premarket notification submitted by Olympus America, Inc. for the device "OLYMPUS HDL CHOLESTEROL REAGENT, OSR6195/OSR6295 AND OLYMPUS HDL CHOLESTEROL CALIBRATOR ODC0023". The FDA issued a decision of Substantially Equivalent on April 8, 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.