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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gram-Positive Bacteria And Their Resistance Markers
510(k) Number K122514
Device Name VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST
Applicant
Nanosphere, Inc.
4088 Commercial Ave.
Northbrook,  IL  60062
Applicant Contact MARK DEL VECCHIO
Correspondent
Nanosphere, Inc.
4088 Commercial Ave.
Northbrook,  IL  60062
Correspondent Contact MARK DEL VECCHIO
Regulation Number866.3365
Classification Product Code
PAM  
Date Received08/17/2012
Decision Date 09/19/2012
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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