FDA 510(k) Application Details - K023312

Device Classification Name	Control, Plasma, Abnormal   More FDA Info for this Device
510(K) Number	K023312
Device Name	Control, Plasma, Abnormal
Applicant	DADE BEHRING, INC. 514 GBC DR. NEWARK, DE 19702 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	GGC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/03/2002
Decision Date	11/01/2002
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