FDA 510(k) Applications for Medical Device Product Code: JHW (U.V. Method, Cpk Isoenzymes)

FDA 510(k) Applications for Medical Device Product Code "JHW"
(U.V. Method, Cpk Isoenzymes)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K961501	BOEHRINGER MANNHEIM CORP.	ELECSYS CK-MB	06/11/1996
K122083	ELITECHGROUP	ELITECH CLINICAL SYSTEMS CK NAC SL	08/22/2012
K141265	ELITECHGROUP	ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT	07/18/2014
K162526	ROCHE DIAGNOSTICS	Creatine Kinase-MB	05/26/2017
K003158	ROCHE DIAGNOSTICS CORP.	ROCHE DIAGNOSTICS CK-MB	12/18/2000
K023744	WIENER LABORATORIES S.A.I.C.	WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354	01/03/2003