SANDARE GLYCOHEMOGLOBIN PROCEDURE

SANDARE GLYCOHEMOGLOBIN PROCEDURE is an FDA 510(k)-cleared medical device (K802832) manufactured by Sandare Chemical Co., Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 15, 1981. Regulation: 8.