KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT

KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT is an FDA 510(k)-cleared medical device (K070183) manufactured by Kronus Market Development Associates, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 12, 2007. Regulation: 8.