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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection
510(k) Number K124006
Device Name ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY
Applicant
Illumina, Inc.
5200 Illumina Way
San Diego,  CA  92122
Applicant Contact LEANNE M KIVIHARJU
Correspondent
Illumina, Inc.
5200 Illumina Way
San Diego,  CA  92122
Correspondent Contact LEANNE M KIVIHARJU
Regulation Number866.5900
Classification Product Code
PFR  
Date Received12/26/2012
Decision Date 11/19/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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