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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 K083088
Device Name VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST
Original Applicant
NANOSPHERE, INC
4088 commercial avenue
northbrook,  IL  60062
Original Contact gregory w shipp
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Code
NSU  
Date Received10/16/2008
Decision Date 05/01/2009
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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