K-number	K063243
Device name	VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448
Applicant	bioMerieux, Inc.
Product code	MMI
Device class	Class II
Decision date	Dec 14, 2007
Decision	Substantially Equivalent
Regulation	862.1215

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VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448

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