FDA 510(k) Application Details - K964963

Device Classification Name	Plasma, Coagulation Control   More FDA Info for this Device
510(K) Number	K964963
Device Name	Plasma, Coagulation Control
Applicant	BIO-RAD 3726 EAST MIRALOMA AVE. ANAHEIM, CA 92806 US Other 510(k) Applications for this Company
Contact	ELIZABETH PLATT 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	12/11/1996
Decision Date	02/20/1997
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