FDA 510(k) Application Details - K050119

Device Classification Name	Immunochemical, Bence-Jones Protein   More FDA Info for this Device
510(K) Number	K050119
Device Name	Immunochemical, Bence-Jones Protein
Applicant	BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. P.O. BOX 8000, M/S W-515 BREA, CA 92822-8000 US Other 510(k) Applications for this Company
Contact	KIM WALKER Other 510(k) Applications for this Contact
Regulation Number	866.5150   More FDA Info for this Regulation Number
Classification Product Code	JKM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/18/2005
Decision Date	05/06/2005
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