LYPHOCHEK ASSAYED CHEMISTRY CONTROL (HUMAN), I/II

LYPHOCHEK ASSAYED CHEMISTRY CONTROL (HUMAN), I/II is an FDA 510(k)-cleared medical device (K874280) 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 20, 1988. Regulation: 8.