FDA 510(k) Application Details - K093848

Device Classification Name	Plasma, Coagulation Control   More FDA Info for this Device
510(K) Number	K093848
Device Name	Plasma, Coagulation Control
Applicant	DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 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	GGN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/16/2009
Decision Date	12/20/2010
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