FDA 510(k) Application Details - K042941

Device Classification Name	Plasma, Control, Normal   More FDA Info for this Device
510(K) Number	K042941
Device Name	Plasma, Control, Normal
Applicant	DADE BEHRING, INC. GLASCO B500 M.S. 514 P.O. BOX 6101 NEWARK, DE 19714-6101 US Other 510(k) Applications for this Company
Contact	RADAMES RIESGO 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	10/25/2004
Decision Date	12/02/2004
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