FDA 510(k) Application Details - K182095

Device Classification Name	Transferrin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K182095
Device Name	Transferrin, Antigen, Antiserum, Control
Applicant	Roche Diagnostics Operations (RDO) 9115 Hague Road Indianapolis, IN 46250 US Other 510(k) Applications for this Company
Contact	Lindsay Jones Other 510(k) Applications for this Contact
Regulation Number	866.5880   More FDA Info for this Regulation Number
Classification Product Code	DDG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/03/2018
Decision Date	11/05/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review