IMMULITE 2500 OM-MA, MODEL L5KOP

IMMULITE 2500 OM-MA, MODEL L5KOP is an FDA 510(k)-cleared medical device (K072794) manufactured by Siemens Medical Solutions Diagnostics. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 4, 2007. Regulation: 8.