IL TEST(TM) DAT CALIBRATOR A( -)

IL TEST(TM) DAT CALIBRATOR A( -) is an FDA 510(k)-cleared medical device (K913739) manufactured by Instrumentation Laboratory CO. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 9, 1991. Regulation: 8.