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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, Variant Gene Sequence Detection
510(k) Number K132750
FOIA Releasable 510(k) K132750
Device Name ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY
Applicant
Illumina, Inc.
5200 Illumina Way
San Diego,  CA  92122
Applicant Contact BRYAN SCHNEIDER
Correspondent
Illumina, Inc.
5200 Illumina Way
San Diego,  CA  92122
Correspondent Contact BRYAN SCHNEIDER
Regulation Number866.5900
Classification Product Code
PFS  
Date Received09/03/2013
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
Recalls CDRH Recalls
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