LYPHOCHEK UNASSAYED CHEMISTRY CONTROL LEVEL 3

LYPHOCHEK UNASSAYED CHEMISTRY CONTROL LEVEL 3 is an FDA 510(k)-cleared medical device (K922046) 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 July 9, 1992. Regulation: 8.