QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3

QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3 is an FDA 510(k)-cleared medical device (K993715) manufactured by Seracare Technology. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 15, 1999. Regulation: 8.