FDA 510(k) Application Details - K032035

Device Classification Name	Complement C3, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K032035
Device Name	Complement C3, Antigen, Antiserum, Control
Applicant	BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 BREA, CA 92822 US Other 510(k) Applications for this Company
Contact	KIM WALKER Other 510(k) Applications for this Contact
Regulation Number	866.5240   More FDA Info for this Regulation Number
Classification Product Code	CZW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/01/2003
Decision Date	08/07/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review