FDA 510(k) Application Details - K041793

Device Classification Name	Ferrozine (Colorimetric) Iron Binding Capacity   More FDA Info for this Device
510(K) Number	K041793
Device Name	Ferrozine (Colorimetric) Iron Binding Capacity
Applicant	OLYMPUS AMERICA, INC. 3131 WEST ROYAL LN. IRVING, TX 75063-3104 US Other 510(k) Applications for this Company
Contact	BEV HARDING 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	07/02/2004
Decision Date	07/16/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review