SIMULTEST(TM) IMK-LYMPHOCYTE

SIMULTEST(TM) IMK-LYMPHOCYTE is an FDA 510(k)-cleared medical device (K913192) 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 February 5, 1992. Regulation: 8.