VARIANT II HEMOGLOBIN A1C PROGRAM

VARIANT II HEMOGLOBIN A1C PROGRAM is an FDA 510(k)-cleared medical device (K984268) manufactured by Bio-Rad. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 16, 1998. Regulation: 8.