HA/5 HEMATOLOGY ANALYZER

HA/5 HEMATOLOGY ANALYZER is an FDA 510(k)-cleared medical device (K760581) 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 November 8, 1976. Regulation: 8.