K-number	K163626
Device name	ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit
Applicant	Luminex Corporation
Product code	OZZ
Device class	Class II
Decision date	May 2, 2017
Decision	Substantially Equivalent
Regulation	866.3980

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View the full FDA submission: accessdata.fda.gov

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ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit

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