FDA 510(k) Application Details - K012722

Device Classification Name	Plasma, Coagulation Control   More FDA Info for this Device
510(K) Number	K012722
Device Name	Plasma, Coagulation Control
Applicant	BIO-RAD 9500 JERONIMO RD. IRVINE, CA 92618-2017 US Other 510(k) Applications for this Company
Contact	MARIA ZEBALLOS 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	08/15/2001
Decision Date	09/18/2001
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