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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 K103209
Device Name VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+)
Applicant
NANOSPHERE, INC.
4088 COMMERCIAL AVENUE
NORTHBROOK,  IL  60062
Applicant Contact GREGORY W SHIPP
Correspondent
NANOSPHERE, INC.
4088 COMMERCIAL AVENUE
NORTHBROOK,  IL  60062
Correspondent Contact GREGORY W SHIPP
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Code
NSU  
Date Received11/01/2010
Decision Date 01/10/2011
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
Recalls CDRH Recalls
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