IMMULITE 2000 OM-MA MODEL L2KOP2

IMMULITE 2000 OM-MA MODEL L2KOP2 is an FDA 510(k)-cleared medical device (K983391) manufactured by Diagnostic Products Corp.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 14, 1998. Regulation: 8.