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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 K163347
Device Name xTAG Cystic Fibrosis 39 Kit v2
Applicant
Luminex Molecular Diagnostics, Inc.
439 University Ave
Toronto,  CA M5g1y8
Applicant Contact Tina Ip
Correspondent
Luminex Molecular Diagnostics, Inc.
439 University Ave
Toronto,  CA M5g1y8
Correspondent Contact Tina Ip
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
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