K-number	K070640
Device name	ARCHITECT STAT TROPONIN-1; MYOGLOBIN
Applicant	Fisher Diagnostics
Product code	MMI
Device class	Class II
Decision date	Sep 13, 2007
Decision	Substantially Equivalent
Regulation	862.1215

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View the full FDA submission: accessdata.fda.gov

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ARCHITECT STAT TROPONIN-1; MYOGLOBIN

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