ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10

ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10 is an FDA 510(k)-cleared medical device (K011853) manufactured by Bio-Rad. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 16, 2001. Regulation: 8.