
Nano-Ditech Co.
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NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN is an FDA 510(k)-cleared medical device (K050975) manufactured by Nano-Ditech Co.. 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 March 1, 2006. Regulation: 8.