FDA 510(k) Application Details - K151578

Device Classification Name	Enzyme Immunoassay, Carbamazepine   More FDA Info for this Device
510(K) Number	K151578
Device Name	Enzyme Immunoassay, Carbamazepine
Applicant	Roche Diagnostics Operations (RDO) 9115 Hague Road Indianapolis, IN 46250 US Other 510(k) Applications for this Company
Contact	David Tribbett Other 510(k) Applications for this Contact
Regulation Number	862.3645   More FDA Info for this Regulation Number
Classification Product Code	KLT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/11/2015
Decision Date	10/22/2015
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