HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704

HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704 is an FDA 510(k)-cleared medical device (K032203) manufactured by Hemocue, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 24, 2003. Regulation: 8.