FDA 510(k) Application Details - K060264

Device Classification Name	Photometric Method, Iron (Non-Heme)   More FDA Info for this Device
510(K) Number	K060264
Device Name	Photometric Method, Iron (Non-Heme)
Applicant	DADE BEHRING, INC. P.O. BOX 6101 BUILDING 500 GLASGOW BUSINESS COMMUNITY NEWARK,, DE 19714 US Other 510(k) Applications for this Company
Contact	ANDREA M TASKER Other 510(k) Applications for this Contact
Regulation Number	862.1410   More FDA Info for this Regulation Number
Classification Product Code	JIY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/01/2006
Decision Date	03/08/2006
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