PROTOTRO/PROTEOLYTIC ENZYME CONTROL

PROTOTRO/PROTEOLYTIC ENZYME CONTROL is an FDA 510(k)-cleared medical device (K831297) manufactured by American Dade. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 7, 1983. Regulation: 8.