Name: Predicase
Price: 199 USD

K-number	K050975
Device name	NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN
Applicant	Nano-Ditech Co.
Product code	MMI
Device class	Class II
Decision date	Mar 2, 2006
Decision	Substantially Equivalent
Regulation	862.1215

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Source

View the full FDA submission: accessdata.fda.gov

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NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN

Everything you need for a 510(k) submission. Nothing you don't.