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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drug Metabolizing Enzyme Genotyping Systems
510(k) Number K120466
Device Name VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)
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 Number862.3360
Classification Product Code
NTI  
Subsequent Product Code
NSU  
Date Received02/15/2012
Decision Date 11/06/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
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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