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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cytochrome p450 2c9 (cyp450 2c9) drug metabolizing enzyme genotyping system
510(k) Number K070804
Device Name VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST
Original Applicant
NANOSPHERE, INC
4088 commercial avenue
northbrook,  IL  60062
Original Contact sue kent
Regulation Number862.3360
Classification Product Code
ODW  
Subsequent Product Codes
NSU   ODV  
Date Received03/23/2007
Decision Date 09/17/2007
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
Recalls CDRH Recalls
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