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Aalto Scientific, Ltd.
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AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5 is an FDA 510(k)-cleared medical device (K100716) manufactured by Aalto Scientific, Ltd.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 22, 2011. Regulation: 8.