DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT

DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT is an FDA 510(k)-cleared medical device (K133803) 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 August 5, 2014. Regulation: 8.