FDA 510(k) Application Details - K012340

Device Classification Name	Ferrozine (Colorimetric) Iron Binding Capacity   More FDA Info for this Device
510(K) Number	K012340
Device Name	Ferrozine (Colorimetric) Iron Binding Capacity
Applicant	BAYER CORP. 511 BENEDICT AVE. TARRYTOWN, NY 10591-5097 US Other 510(k) Applications for this Company
Contact	KENNETH T EDDS 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	07/24/2001
Decision Date	10/01/2001
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