510(k) K060201

OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105. by Olympus America, Inc. — Product Code DHR

K060201 is an FDA 510(k) premarket notification submitted by Olympus America, Inc. for the device "OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105.". The FDA issued a decision of Substantially Equivalent on June 6, 2006. The device falls under product code DHR (System, Test, Rheumatoid Factor), a Class II device regulated under 21 CFR 866.5775. Olympus America, Inc. has at least 10 other 510(k) clearances on record.