DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT

DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT is an FDA 510(k)-cleared medical device (K042193) manufactured by Diazyme Laboratories. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 28, 2004. Regulation: 8.