FDA 510(k) Application Details - K113072

Device Classification Name	Albumin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K113072
Device Name	Albumin, Antigen, Antiserum, Control
Applicant	ROCHE DIAGNOSTICS OPERATIONS 9115 Hague Rd Indianapolis, IN 46256 US Other 510(k) Applications for this Company
Contact	PATRICK STIMART Other 510(k) Applications for this Contact
Regulation Number	866.5040   More FDA Info for this Regulation Number
Classification Product Code	DCF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/17/2011
Decision Date	05/14/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review