ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE

ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE is an FDA 510(k)-cleared medical device (K042015) manufactured by Bayer Healthcare, Diagnostics Division. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 28, 2004. Regulation: 8.