GLYCOSAL II HBA 1C TEST

GLYCOSAL II HBA 1C TEST is an FDA 510(k)-cleared medical device (K011933) manufactured by Provalis Diagnostics , Ltd.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 1, 2001. Regulation: 8.