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


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact