Name: Predicase
Price: 199 USD

K-number	K081674
Device name	BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG)
Applicant	The Binding Site, Ltd.
Product code	MST
Device class	Class II
Decision date	Oct 15, 2008
Decision	Substantially Equivalent
Regulation	866.5750

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Source

View the full FDA submission: accessdata.fda.gov

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BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG)

Everything you need for a 510(k) submission. Nothing you don't.