FDA 510(k) Application Details - K110736

Device Classification Name	Ferritin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K110736
Device Name	Ferritin, Antigen, Antiserum, Control
Applicant	Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVENUE TARRYTOWN, NY 10509 US Other 510(k) Applications for this Company
Contact	KIRA GORDON 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	03/16/2011
Decision Date	08/17/2011
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