FDA 510(k) Applications for Medical Device Product Code: CFE (Electrophoretic, Lactate Dehydrogenase Isoenzymes)

FDA 510(k) Applications for Medical Device Product Code "CFE"
(Electrophoretic, Lactate Dehydrogenase Isoenzymes)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K802628	BECKMAN INSTRUMENTS, INC.	PARAGON ELECTROPHORESIS LACTATE REAG.KIT	12/11/1980
K791827	CLINICAL SCIENCES, INC.	LDH CLINI GEL KIT	10/01/1979
K841433	CORNING MEDICAL & SCIENTIFIC	CORNING LACTATE DEHYDROPHORETIC ASSAY	05/16/1984
K780080	CORNING MEDICAL & SCIENTIFIC	LACTATE DEHYDROGENASE COLORIMETRIC SUB.	02/07/1978
K800568	CORNING MEDICAL & SCIENTIFIC	TRANSPHOR TM LD LACTATE DEHYDROGENASE	04/04/1980
K921455	E.I. DUPONT DE NEMOURS & CO., INC.	ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD	04/29/1992
K905861	E.I. DUPONT DE NEMOURS & CO., INC.	ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1 (LD1) METH	02/06/1991
K790311	ELECTROPHORESIS CORP.	LDH ISOENZYME REAGENT	03/21/1979
K791656	ELECTROPHORESIS CORP. OF AMERICA	ENZYME STABILIZING REAGENT (ESR)	09/17/1979
K781125	ELECTROPHORESIS CORP. OF AMERICA	LDH ISOENZYME REAGENT	08/10/1978
K791657	ELECTROPHORESIS CORP. OF AMERICA	LDH ISOENZYME REAGENT	09/17/1979
K832314	EM INDUSTRIES, INC.	CARDIZYME PLUS LD #65094/93	09/01/1983
K940224	HELENA LABORATORIES	CARDIO REP LD	08/17/1994
K861750	HELENA LABORATORIES	CK/LD BUFFER (CAT. NO. 5808)	05/29/1986
K892818	HELENA LABORATORIES	REP(TM) LD-2 STAT KIT, CAT. NO. 3078	06/20/1989
K020467	HELENA LABORATORIES	SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452	03/29/2002
K022455	HELENA LABORATORIES	SPIFE LD-12 KIT, MODEL 3338	10/01/2002
K842669	HELENA LABORATORIES	TITAN GEL ISO DOT LDH KIT	11/09/1984
K830872	HELENA LABORATORIES	TITAN GEL LDH ISO-ENZYME CONTROL	04/12/1983
K873386	HELENA LABORATORIES	TITAN GEL LDH REP SYSTEM	10/20/1987
K874143	HELENA LABORATORIES	TITAN GEL REP LDH-12 HV	11/23/1987
K874142	HELENA LABORATORIES	TITAN GEL REP LDH-30 HV	11/24/1987
K874145	HELENA LABORATORIES	TITAN GEL REP LDH-6 HV	11/24/1987
K791373	HOFFMANN-LA ROCHE, INC.	ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS	10/26/1979
K894081	ROCHE DIAGNOSTIC SYSTEMS, INC.	ROCHO ISOMUNE - LD	08/31/1989
K850210	SCLAVO, INC.	ISOENZYME TEST LD-1	03/29/1985
K100307	SEBIA	GELSCAN, MODEL 1206	08/31/2010
K970477	SEBIA	HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT	03/10/1997

FDA 510(k) Applications for Medical Device Product Code "CFE" (Electrophoretic, Lactate Dehydrogenase Isoenzymes)

FDA 510(k) Applications for Medical Device Product Code "CFE"
(Electrophoretic, Lactate Dehydrogenase Isoenzymes)