AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET

AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET is an FDA 510(k)-cleared medical device (K130762) 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 April 28, 2013. Regulation: 8.