GLUCOSE (HEXOKINASE) DELTA TEST ASSAY

GLUCOSE (HEXOKINASE) DELTA TEST ASSAY is an FDA 510(k)-cleared medical device (K770262) manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 22, 1977. Regulation: 8.