K-number	K100917
Device name	FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM
Applicant	Biomedical Diagnostics (Bmd) SA
Product code	MOB
Device class	Class II
Decision date	Nov 3, 2010
Decision	Substantially Equivalent
Regulation	866.5660

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View the full FDA submission: accessdata.fda.gov

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FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM

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