FDA 510(k) Application Details - K073071

Device Classification Name	Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System   More FDA Info for this Device
510(K) Number	K073071
Device Name	Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
Applicant	TRIMGEN CORPORATION 34 LOVETON CIRCLE, SUITE 210 SPARKS, MD 21152-9202 US Other 510(k) Applications for this Company
Contact	HOWARD DOONG Other 510(k) Applications for this Contact
Regulation Number	862.3360   More FDA Info for this Regulation Number
Classification Product Code	ODW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/31/2007
Decision Date	02/06/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review