LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529

LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529 is an FDA 510(k)-cleared medical device (K020610) manufactured by Bio-Rad. This device is classified under the Clinical Toxicology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 21, 2002. Regulation: 8.