IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6

IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6 is an FDA 510(k)-cleared medical device (K993952) manufactured by Diagnostic Products Corp.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 15, 1999. Regulation: 8.