Name: Predicase
Price: 199 USD

K-number	K083294
Device name	VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST
Applicant	Nanosphere, Inc.
Product code	NUA
Device class	Class II
Decision date	Jul 24, 2009
Decision	Substantially Equivalent
Regulation	866.5900

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Source

View the full FDA submission: accessdata.fda.gov

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VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST

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