LYPHOCHEK WHOLE BLOOD CONTROL (HUMAN) LEVELS 1,2,3

LYPHOCHEK WHOLE BLOOD CONTROL (HUMAN) LEVELS 1,2,3 is an FDA 510(k)-cleared medical device (K895905) 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 January 17, 1990. Regulation: 8.