K-number	DEN120014
Device name	VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP)
Applicant	Nanosphere, Inc.
Product code	PAM
Device class	Class II
Decision date	Jun 26, 2012
Decision	Not Substantially Equivalent
Regulation	866.3365

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VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP)

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