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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 K101683
Device Name INFINITI CYP2C19 ASSAY
Applicant
AUTOGENOMICS, INCORPORATED
2980 SCOTT STREET
VISTA,  CA  92081
Applicant Contact EVELYN G LOPEZ
Correspondent
AUTOGENOMICS, INCORPORATED
2980 SCOTT STREET
VISTA,  CA  92081
Correspondent Contact EVELYN G LOPEZ
Regulation Number862.3360
Classification Product Code
NTI  
Subsequent Product Code
NSU  
Date Received06/15/2010
Decision Date 10/25/2010
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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