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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
Original Applicant
NANOSPHERE, INC
4088 commercial avenue
northbrook,  IL  60062
Original 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 (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
statement statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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