SERIES 810 PLATELET ANALYZER

SERIES 810 PLATELET ANALYZER is an FDA 510(k)-cleared medical device (K803128) manufactured by J.T. Baker Chemical Co.. 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 2, 1981. Regulation: 8.