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Aalto Scientific, Ltd.
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AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5 is an FDA 510(k)-cleared medical device (K082717) 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 October 29, 2008. Regulation: 8.