DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR

DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR is an FDA 510(k)-cleared medical device (K871977) manufactured by American Dade. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 8, 1987. Regulation: 8.