FDA 510(k) Applications for Medical Device Product Code: JHS (Differential Rate Kinetic Method, Cpk Or Isoenzymes)

FDA 510(k) Applications for Medical Device Product Code "JHS"
(Differential Rate Kinetic Method, Cpk Or Isoenzymes)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K082226	ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.	S40 CREATINE KINASE (CK)	09/18/2008
K990439	CARESIDE, INC.	CARESIDE CK	04/19/1999
K990434	CARESIDE, INC.	CARESIDE CKMB	04/19/1999
K962126	CIBA CORNING DIAGNOSTICS CORP.	ACS CKMB II IMMUNOASSAY	06/21/1996
K062128	DADE BEHRING, INC.	THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS	08/21/2006
K981495	DIAGNOSTIC PRODUCTS CORP.	IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS)	06/10/1998
K160570	Roche Diagnostics Operations (RDO)	Creatine Kinase	05/25/2016
K102706	SENTINEL CH. SpA	CKMB UDR ASSAY	08/19/2011