K-number	K110899
Device name	GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT
Applicant	Gold Standard Diagnostics
Product code	LYR
Device class	Class I
Decision date	Feb 1, 2012
Decision	Substantially Equivalent
Regulation	866.3110

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Source

View the full FDA submission: accessdata.fda.gov

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GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT

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