K-number	K163367
Device name	GenetiSure Dx Postnatal Assay
Applicant	Agilent Technologies, Inc.
Product code	PFX
Device class	Class II
Decision date	Aug 11, 2017
Decision	Substantially Equivalent
Regulation	866.5920

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Source

View the full FDA submission: accessdata.fda.gov

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GenetiSure Dx Postnatal Assay

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