FDA 510(k) Applications for Medical Device Product Code: JKM (Immunochemical, Bence-Jones Protein)

FDA 510(k) Applications for Medical Device Product Code "JKM"
(Immunochemical, Bence-Jones Protein)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K050119	BECKMAN COULTER, INC.	PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT	05/06/2005
K972591	MORAX	HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT	03/04/1998
K080916	SEBIA	CAPILLARYS URINE	07/01/2008
K070486	Sebia, Inc.	CAPILLARYS URINE (PN 2012)	12/21/2007