FDA 510(k) Application Details - K113438

Device Classification Name	Ferrozine (Colorimetric) Iron Binding Capacity   More FDA Info for this Device
510(K) Number	K113438
Device Name	Ferrozine (Colorimetric) Iron Binding Capacity
Applicant	ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. 4 HENDERSON DRIVE WEST CALDWELL, NJ 07006 US Other 510(k) Applications for this Company
Contact	HYMAN KATZ Other 510(k) Applications for this Contact
Regulation Number	862.1415   More FDA Info for this Regulation Number
Classification Product Code	JMO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/2011
Decision Date	06/01/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review