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Mitsubishi Kagaku Iatron
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PATHFAST NTPROBNP AND D-DIMER TESTS is an FDA 510(k)-cleared medical device (K072189) manufactured by Mitsubishi Kagaku Iatron. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 4, 2008. Regulation: 8.