CALCIUM-ARSENAZO III REAGENT SET

CALCIUM-ARSENAZO III REAGENT SET is an FDA 510(k)-cleared medical device (K921625) manufactured by Pointe Scientific, 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 May 12, 1992. Regulation: 8.