EQ-PRC LC WARFARIN GENOTYPING KIT


Device Classification Name

cytochrome p450 2c9 (cyp450 2c9) drug metabolizing enzyme genotyping system

510(k) Number K073071
Device Name EQ-PRC LC WARFARIN GENOTYPING KIT
Applicant
TRIMGEN CORPORATION
34 loveton circle, suite 210
sparks, 
MD 
21152 -9202

Applicant Contact howard doong
Correspondent
TRIMGEN CORPORATION
34 loveton circle, suite 210
sparks, 
MD 
21152 -9202

Correspodent Contact howard doong
Regulation Number 862.3360
Classification Product Code
ODW  
Subsequent Product Codes
NSU   ODV  
Date Received 10/31/2007
Decision Date 02/06/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No