OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117

OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 is an FDA 510(k)-cleared medical device (K061575) manufactured by Olympus America, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 4, 2006. Regulation: 8.