FDA 510(k) Application Details - K130189

Device Classification Name	Drug Metabolizing Enzyme Genotyping Systems   More FDA Info for this Device
510(K) Number	K130189
Device Name	Drug Metabolizing Enzyme Genotyping Systems
Applicant	LUMINEX MOLECULAR DIAGNOSTICS, INC. 439 UNIVERSITY AVE. TORONTO, ONTARIO M5G 1Y8 CA Other 510(k) Applications for this Company
Contact	LUBNA SYED Other 510(k) Applications for this Contact
Regulation Number	862.3360   More FDA Info for this Regulation Number
Classification Product Code	NTI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/25/2013
Decision Date	05/21/2013
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