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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
510(k) Number K140083
Device Name VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP)
Applicant
Nanosphere, Inc.
4088 Commercial Ave.
Northbrook,  IL  60062
Applicant Contact Teresa Raich
Correspondent
Nanosphere, Inc.
4088 Commercial Ave.
Northbrook,  IL  60062
Correspondent Contact Teresa Raich
Regulation Number866.3990
Classification Product Code
PCH  
Subsequent Product Codes
OOI   PCI  
Date Received01/13/2014
Decision Date 06/20/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
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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