FDA 510(k) Application Details - K970248

Device Classification Name	Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity   More FDA Info for this Device
510(K) Number	K970248
Device Name	Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity
Applicant	CANYON DIAGNOSTICS, INC. 4075 LEAVERTON COURT ANAHEIM, CA 92807 US Other 510(k) Applications for this Company
Contact	ANTHONY FALKOWSKI Other 510(k) Applications for this Contact
Regulation Number	862.1415   More FDA Info for this Regulation Number
Classification Product Code	JQE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/22/1997
Decision Date	02/11/1997
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