Electrophoretic, Lactate Dehydrogenase Isoenzymes

FDA product code CFE · Class II (moderate risk) · 21 CFR 862.1445 · Clinical Chemistry

28510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K100307Gelscan, Model 1206CFE · Traditional Sebia08/31/2010SE
K022455Spife LD-12 Kit, Model 3338CFE · Traditional Helena Laboratories10/01/2002SE
K020467Spife LD Vis Isoenzyme Kit, Models 3450, 3451, and 3452CFE · Traditional Helena Laboratories03/29/2002SE
K970477Hyragel Iso-Ldh Kit/Hydragel 15 Iso-Ldh KitCFE · Traditional Sebia03/10/1997SE
K940224Cardio Rep LDCFE · Traditional Helena Laboratories08/17/1994SE
K921455Aca Lactate Dehydrogenase Isoenzyme 1 (LD1) MethodCFE · Traditional E.I. Dupont DE Nemours & Co., Inc.04/29/1992SE
K905861Aca(R) Lactic Dehydrogenase Isoenzyme 1 (LD1) MethCFE · Traditional E.I. Dupont DE Nemours & Co., Inc.02/06/1991SE
K894081Rocho Isomune - LDCFE · Traditional Roche Diagnostic Systems, Inc.08/31/1989SE
K892818Rep(Tm) LD-2 Stat Kit, Cat. No. 3078CFE · Traditional Helena Laboratories06/20/1989SE
K874145Titan Gel Rep LDH-6 HVCFE · Traditional Helena Laboratories11/24/1987SE
K874142Titan Gel Rep LDH-30 HVCFE · Traditional Helena Laboratories11/24/1987SE
K874143Titan Gel Rep LDH-12 HVCFE · Traditional Helena Laboratories11/23/1987SE
K873386Titan Gel LDH Rep SystemCFE · Traditional Helena Laboratories10/20/1987SE
K861750Ck/Ld Buffer (Cat. No. 5808)CFE · Traditional Helena Laboratories05/29/1986SE
K850210Isoenzyme Test LD-1CFE · Traditional Sclavo, Inc.03/29/1985SE
K842669Titan Gel Iso Dot LDH KitCFE · Traditional Helena Laboratories11/09/1984SE
K841433Corning Lactate Dehydrophoretic AssayCFE · Traditional Corning Medical & Scientific05/16/1984SE
K832314Cardizyme Plus LD #65094/93CFE · Traditional Em Industries, Inc.09/01/1983SE
K830872Titan Gel LDH Iso-Enzyme ControlCFE · Traditional Helena Laboratories04/12/1983SE
K802628Paragon Electrophoresis Lactate Reag.KitCFE · Traditional Beckman Instruments, Inc.12/11/1980SE
K800568Transphor TM LD Lactate DehydrogenaseCFE · Traditional Corning Medical & Scientific04/04/1980SE
K791373Roche Immunochemical LD Isoenzy ReagentsCFE · Traditional Hoffmann-La Roche, Inc.10/26/1979SE
K791827LDH Clini Gel KitCFE · Traditional Clinical Sciences, Inc.10/01/1979SE
K791657LDH Isoenzyme ReagentCFE · Traditional Electrophoresis Corp. of America09/17/1979SE
K791656Enzyme Stabilizing Reagent (Esr)CFE · Traditional Electrophoresis Corp. of America09/17/1979SE
K790311LDH Isoenzyme ReagentCFE · Traditional Electrophoresis Corp.03/21/1979SE
K781125LDH Isoenzyme ReagentCFE · Traditional Electrophoresis Corp. of America08/10/1978SE
K780080Lactate Dehydrogenase Colorimetric Sub.CFE · Traditional Corning Medical & Scientific02/07/1978SE