IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5

IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5 is an FDA 510(k)-cleared medical device (K981297) 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 September 17, 1998. Regulation: 8.