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Nano-Ditech Corporation
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NANO-CHECK AMI CTNI CARDIAC MARKER TEST is an FDA 510(k)-cleared medical device (K102131) manufactured by Nano-Ditech Corporation. 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 October 19, 2010. Regulation: 8.