IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06

IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06 is an FDA 510(k)-cleared medical device (K991096) 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 May 12, 1999. Regulation: 8.