K-number	K071799
Device name	MODIFICATION TO BIOSTAR OIA SHIGATOX
Applicant	Iverness Medical Professional Diagnostics
Product code	GNA
Device class	Class I
Decision date	Oct 2, 2007
Decision	Substantially Equivalent
Regulation	866.3255

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View the full FDA submission: accessdata.fda.gov

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MODIFICATION TO BIOSTAR OIA SHIGATOX

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