ALKALINE PHOSPHATASE ISOYZME REAGENT SET

ALKALINE PHOSPHATASE ISOYZME REAGENT SET is an FDA 510(k)-cleared medical device (K770155) manufactured by Gelman Instrument Co.. 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 January 30, 1977. Regulation: 8.