FACS ANALYZER

FACS ANALYZER is an FDA 510(k)-cleared medical device (K840195) 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 April 29, 1984. Regulation: 8.