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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gram-Negative Bacteria And Associated Resistance Markers
510(k) Number K132843
Device Name VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)
Applicant
NANOSPHERE, INC
4088 COMMERCIAL AVENUE
NORTHBROOK,  IL  60062
Applicant Contact MARK DEL VECCHIO
Correspondent
NANOSPHERE, INC
4088 COMMERCIAL AVENUE
NORTHBROOK,  IL  60062
Correspondent Contact MARK DEL VECCHIO
Regulation Number866.3365
Classification Product Code
PEN  
Subsequent Product Code
NSU  
Date Received09/10/2013
Decision Date 01/08/2014
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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