AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL

AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL is an FDA 510(k)-cleared medical device (K020618) manufactured by Aalto Scientific, Ltd.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 13, 2002. Regulation: 8.