FDA 510(k) Application Details - K152612

Device Classification Name	Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System   More FDA Info for this Device
510(K) Number	K152612
Device Name	Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
Applicant	GENMARK DIAGNOSTICS, INCORPORATED 5964 LA PLACE COURT CARLSBAD, CA 92008 US Other 510(k) Applications for this Company
Contact	ALAN MADERAZO 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	09/14/2015
Decision Date	05/26/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review