LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580

LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580 is an FDA 510(k)-cleared medical device (K011579) manufactured by Bio-Rad. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 25, 2001. Regulation: 8.