K-number	K965133
Device name	ANCA COMBI DIAGNOSTIC TEST KIT
Applicant	The Binding Site, Ltd.
Product code	MOB
Device class	Class II
Decision date	May 21, 1997
Decision	Substantially Equivalent
Regulation	866.5660

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View the full FDA submission: accessdata.fda.gov

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ANCA COMBI DIAGNOSTIC TEST KIT

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