K-number	K082699
Device name	ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS
Applicant	Roche Diagnostics
Product code	MMI
Device class	Class II
Decision date	Aug 19, 2009
Decision	Substantially Equivalent
Regulation	862.1215

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View the full FDA submission: accessdata.fda.gov

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ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS

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