IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6

IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6 is an FDA 510(k)-cleared medical device (K000257) 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 February 22, 2000. Regulation: 8.