IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER

IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER is an FDA 510(k)-cleared medical device (K033234) manufactured by Diagnostic Products Corp.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 11, 2003. Regulation: 8.