FDA 510(k) Application Details - K170492

Device Classification Name	Drug Metabolizing Enzyme Genotyping Systems   More FDA Info for this Device
510(K) Number	K170492
Device Name	Drug Metabolizing Enzyme Genotyping Systems
Applicant	Luminex Molecular Diagnostics, Inc. 439 University Ave. Toronto M5G 1Y8 CA Other 510(k) Applications for this Company
Contact	Jennifer Grimes 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	02/17/2017
Decision Date	08/11/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review