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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 K083294
Device Name VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST
Applicant
Nanosphere, Inc.
4088 Commercial Ave.
Northbrook,  IL  60062
Applicant Contact GREGORT W SHIPP
Correspondent
Nanosphere, Inc.
4088 Commercial Ave.
Northbrook,  IL  60062
Correspondent Contact GREGORT W SHIPP
Regulation Number866.5900
Classification Product Code
NUA  
Date Received11/10/2008
Decision Date 07/24/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Pathology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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