QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2

QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2 is an FDA 510(k)-cleared medical device (K993631) 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 December 8, 1999. Regulation: 8.