HEMOSIL HOMOCYSTEINE AND CONTROLS

HEMOSIL HOMOCYSTEINE AND CONTROLS is an FDA 510(k)-cleared medical device (K061598) manufactured by Instrumentation Laboratory 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 September 21, 2006. Regulation: 8.