510(k) K061575

OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 by Olympus America, Inc. — Product Code CJY

K061575 is an FDA 510(k) premarket notification submitted by Olympus America, Inc. for the device "OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117". The FDA issued a decision of Substantially Equivalent on October 5, 2006. The device falls under product code CJY (Azo Dye, Calcium), a Class II device regulated under 21 CFR 862.1145. Olympus America, Inc. has at least 10 other 510(k) clearances on record.