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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 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
Correspondent Contact HOWARD DOONG
Regulation Number862.3360
Classification Product Code
ODW  
Subsequent Product Codes
NSU   ODV  
Date Received10/31/2007
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
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