COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS

COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS is an FDA 510(k)-cleared medical device (K022550) manufactured by Instrumentation Laboratory CO. 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 26, 2002. Regulation: 8.