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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 avenue
northbrook,  IL  60062
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 - CLIA submission (CS)
Classification Advisory Committee Toxicology
Review Advisory Committee Toxicology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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