IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 3

IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 3 is an FDA 510(k)-cleared medical device (K020237) manufactured by Consolidated Technology. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 18, 2002. Regulation: 8.