IMMULITE EPO, MODEL #'S LKEPZ & LKEP1

IMMULITE EPO, MODEL #'S LKEPZ & LKEP1 is an FDA 510(k)-cleared medical device (K983203) manufactured by Diagnostic Products Corp.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 11, 1999. Regulation: 8.