INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN


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

Correspodent Contact evelyn g lopez
Regulation Number 862.3360
Classification Product Code
ODW  
Subsequent Product Codes
NSU   ODV  
Date Received 10/25/2007
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