510(k) K102441

NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN by Nano-Ditech Corporation — Product Code MMI

K102441 is an FDA 510(k) premarket notification submitted by Nano-Ditech Corporation for the device "NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN". The FDA issued a decision of Substantially Equivalent on October 20, 2010. The device falls under product code MMI (Immunoassay Method, Troponin Subunit), a Class II device regulated under 21 CFR 862.1215. Nano-Ditech Corporation has at least 5 other 510(k) clearances on record.