FDA 510(k) Application Details - K171642

Device Classification Name	Ferritin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K171642
Device Name	Ferritin, Antigen, Antiserum, Control
Applicant	Siemens Healthcare Diagnostics Inc. 511 Benedict Ave. Tarrytown, NY 10591 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	06/02/2017
Decision Date	08/31/2017
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