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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
Contact howard doong
Regulation Number862.3360
Classification Product Code
ODW  
Subsequent Product Codes
NSU   ODV  
Date Received11/01/2007
Decision Date 02/06/2009
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Toxicology
Review Advisory Committee Toxicology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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