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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Respiratory Virus Panel Nucleic Acid Assay System
510(k) Number K092957
Device Name VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST
Applicant
Nanosphere, Inc.
4088 Commercial Ave.
Northbrook,  IL  60062
Applicant Contact GREGORY SHIPP
Correspondent
Nanosphere, Inc.
4088 Commercial Ave.
Northbrook,  IL  60062
Correspondent Contact GREGORY SHIPP
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Code
NSU  
Date Received09/25/2009
Decision Date 10/21/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
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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