VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM

VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM is an FDA 510(k)-cleared medical device (K972609) manufactured by Bio-Rad. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 5, 1997. Regulation: 8.