K-number	K124006
Device name	ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY
Applicant	Illumina, Inc.
Product code	PFR
Device class	Class II
Decision date	Nov 19, 2013
Decision	Substantially Equivalent
Regulation	—

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View the full FDA submission: accessdata.fda.gov

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ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY

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