FDA 510(k) Application Details - K063356

Device Classification Name	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K063356
Device Name	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
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	864.7320   More FDA Info for this Regulation Number
Classification Product Code	DAP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/07/2006
Decision Date	03/23/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review