FDA 510(k) Application Details - K030182

Device Classification Name	Plasma, Coagulation Control   More FDA Info for this Device
510(K) Number	K030182
Device Name	Plasma, Coagulation Control
Applicant	BIO-RAD 9500 JERONIMO RD. IRVINE, CA 92618-2017 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	01/17/2003
Decision Date	02/24/2003
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