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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 K073014
Device Name INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN
Applicant
AUTOGENOMICS, INCORPORATED
2251 RUTHERFORD ROAD
CARLSBAD,  CA  92008
Applicant Contact EVELYN G LOPEZ
Correspondent
AUTOGENOMICS, INCORPORATED
2251 RUTHERFORD ROAD
CARLSBAD,  CA  92008
Correspondent Contact EVELYN G LOPEZ
Regulation Number862.3360
Classification Product Code
ODW  
Subsequent Product Codes
NSU   ODV  
Date Received10/25/2007
Decision Date 01/23/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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