IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER

IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER is an FDA 510(k)-cleared medical device (K970227) manufactured by Dpc Cirrus. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 7, 1997. Regulation: 8.