FDA 510(k) Applications for Medical Device Product Code: JHY (Colorimetric Method, Cpk Or Isoenzymes)

FDA 510(k) Applications for Medical Device Product Code "JHY"
(Colorimetric Method, Cpk Or Isoenzymes)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K961412	BAYER CORP.	CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO	06/18/1996
K974421	BOEHRINGER MANNHEIM CORP.	ELECSYS CK-MB STAT	12/17/1997
K970343	DADE CHEMISTRY SYSTEMS, INC.	MMB METHOD	02/14/1997
K022757	HELENA LABORATORIES	SPIFE CK KIT, MODEL 3332, 3333	10/11/2002
K130080	MEDICA CORPORATION	EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL	05/13/2014
K070835	OLYMPUS LIFE & MATERIAL SCIENCE EUROPA GMBH (IRISH	OLYMPUS CK-MB REAGENT	06/04/2007
K140404	Roche Diagnostics	ELECSYS CK-MB STAT IMMUNOASSAY	05/08/2014
K132571	Roche Diagnostics	ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY	10/18/2013
K022654	ROCHE DIAGNOSTICS CORP.	MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB	08/29/2002
K143720	Siemens Healthcare Diagnostics	Dimension Vista MMB Assay	09/18/2015