QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945

QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 is an FDA 510(k)-cleared medical device (K073080) manufactured by Bio-Rad Laboratories. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 23, 2008. Regulation: 8.