PLATELET CONTROL, NORMAL & ABNORMAL

PLATELET CONTROL, NORMAL & ABNORMAL is an FDA 510(k)-cleared medical device (K770095) 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 27, 1977. Regulation: 8.