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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
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