K-number	K133503
Device name	AMPLIVUE GBS ASSAY
Applicant	Quidel Corporation
Product code	NJR
Device class	Class I
Decision date	Dec 20, 2013
Decision	Substantially Equivalent
Regulation	866.3740

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Source

View the full FDA submission: accessdata.fda.gov

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AMPLIVUE GBS ASSAY

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