FDA 510(k) Application Details - K071597

Device Classification Name	Kit, Test,Alpha-Fetoprotein For Testicular Cancer   More FDA Info for this Device
510(K) Number	K071597
Device Name	Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Applicant	DADE BEHRING, INC. P.O. BOX 6101 BLDG 500;M.S.514 NEWARK, DE 19714-6101 US Other 510(k) Applications for this Company
Contact	PAMELA A JURGA Other 510(k) Applications for this Contact
Regulation Number	866.6010   More FDA Info for this Regulation Number
Classification Product Code	LOJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/12/2007
Decision Date	06/04/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review