GLUCOHEMOGLOBIN CONTROL

GLUCOHEMOGLOBIN CONTROL is an FDA 510(k)-cleared medical device (K791428) manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 21, 1979. Regulation: 8.