FDA 510(k) Application Details - K100538

Device Classification Name	Ferritin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K100538
Device Name	Ferritin, Antigen, Antiserum, Control
Applicant	Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 US Other 510(k) Applications for this Company
Contact	KATHIE J GOODWIN Other 510(k) Applications for this Contact
Regulation Number	866.5340   More FDA Info for this Regulation Number
Classification Product Code	DBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/25/2010
Decision Date	06/22/2010
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