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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 Mutation Detection
510(k) Number K163336
Device Name xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR
Applicant
Luminex Molecular Diagnostics, Inc.
439 University Ave.
Toronto,  CA M5G 1Y8
Applicant Contact Jennifer Grimes
Correspondent
Luminex Molecular Diagnostics, Inc.
439 University Ave.
Toronto,  CA M5G 1Y8
Correspondent Contact Jennifer Grimes
Regulation Number866.5900
Classification Product Code
NUA  
Date Received11/28/2016
Decision Date 12/15/2016
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Immunology
510k Review Panel Molecular Genetics
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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