Audit MicroControls Linearity FD Tumor Markers II

Audit MicroControls Linearity FD Tumor Markers II is an FDA 510(k)-cleared medical device (K163629) manufactured by Aalto Scientific, Ltd.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 9, 2017. Regulation: 8.