OLYMPUS CALCIUM ARSENAZO III REAGENT

OLYMPUS CALCIUM ARSENAZO III REAGENT is an FDA 510(k)-cleared medical device (K982035) manufactured by Olympus Diagnostica GmbH. 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 June 23, 1998. Regulation: 8.