K-number	K110745
Device name	HELICOBACTER PYLORI ELISA IGG TEST KIT
Applicant	Gold Standard Diagnostics
Product code	LYR
Device class	Class I
Decision date	Mar 2, 2012
Decision	Substantially Equivalent
Regulation	—

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View the full FDA submission: accessdata.fda.gov

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HELICOBACTER PYLORI ELISA IGG TEST KIT

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