FDA 510(k) Application Details - K052867

Device Classification Name	Ferrozine (Colorimetric) Iron Binding Capacity   More FDA Info for this Device
510(K) Number	K052867
Device Name	Ferrozine (Colorimetric) Iron Binding Capacity
Applicant	Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. ROCHESTER, NY 14626-5101 US Other 510(k) Applications for this Company
Contact	Darlene J Phillips 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	10/11/2005
Decision Date	12/23/2005
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