QUALITROL DHP IMMUNOASSAY CONTROL, LEVELS 1,2, AND 3

QUALITROL DHP IMMUNOASSAY CONTROL, LEVELS 1,2, AND 3 is an FDA 510(k)-cleared medical device (K001249) manufactured by Consolidated Technologies of Wisconsin. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 1, 2000. Regulation: 8.