IMMULITE 2000 3RD GENERATION PSA

IMMULITE 2000 3RD GENERATION PSA is an FDA 510(k)-cleared medical device (K974842) 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 April 20, 1998. Regulation: 8.