K-number	K042579
Device name	BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT
Applicant	The Binding Site
Product code	NBT
Device class	Class II
Decision date	Jul 28, 2005
Decision	Substantially Equivalent
Regulation	866.5785

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View the full FDA submission: accessdata.fda.gov

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BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT

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