LIQUI-HEME GLYCO A1C ASSAY

LIQUI-HEME GLYCO A1C ASSAY is an FDA 510(k)-cleared medical device (K031296) manufactured by Biodiagnostic Intl. 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 14, 2004. Regulation: 8.