FDA 510(k) Application Details - K001256

Device Classification Name	Plasma, Control, Normal   More FDA Info for this Device
510(K) Number	K001256
Device Name	Plasma, Control, Normal
Applicant	DADE BEHRING, INC. PO BOX 6101 NEWARK, DE 19714-6101 US Other 510(k) Applications for this Company
Contact	DONNA A WOLF Other 510(k) Applications for this Contact
Regulation Number	864.5425   More FDA Info for this Regulation Number
Classification Product Code	GIZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/19/2000
Decision Date	05/24/2000
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