FDA 510(k) Application Details - K123891

Device Classification Name	Drug Metabolizing Enzyme Genotyping Systems   More FDA Info for this Device
510(K) Number	K123891
Device Name	Drug Metabolizing Enzyme Genotyping Systems
Applicant	SPARTAN BIOSCIENCE INC 3 LAGOON DRIVE, STE 280 REDWOOD SHORES, CA 94065 US Other 510(k) Applications for this Company
Contact	LORRY HUFFMAN 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	12/18/2012
Decision Date	08/12/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review