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CFE — Electrophoretic, Lactate Dehydrogenase Isoenzymes Class II

FDA Device Classification

Classification Details

Product Code
CFE
Device Class
Class II
Regulation Number
862.1445
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K100307sebiaGELSCAN, MODEL 1206August 31, 2010
K022455helena laboratoriesSPIFE LD-12 KIT, MODEL 3338October 1, 2002
K020467helena laboratoriesSPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452March 29, 2002
K970477sebiaHYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KITMarch 10, 1997
K940224helena laboratoriesCARDIO REP LDAugust 17, 1994
K921455e.i. dupont de nemours and coACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHODApril 29, 1992
K905861e.i. dupont de nemours and coACA(R) LACTIC DEHYDROGENASE ISOENZYME 1 (LD1) METHFebruary 6, 1991
K894081roche diagnostic systemsROCHO ISOMUNE - LDAugust 31, 1989
K892818helena laboratoriesREP(TM) LD-2 STAT KIT, CAT. NO. 3078June 20, 1989
K874145helena laboratoriesTITAN GEL REP LDH-6 HVNovember 24, 1987
K874142helena laboratoriesTITAN GEL REP LDH-30 HVNovember 24, 1987
K874143helena laboratoriesTITAN GEL REP LDH-12 HVNovember 23, 1987
K873386helena laboratoriesTITAN GEL LDH REP SYSTEMOctober 20, 1987
K861750helena laboratoriesCK/LD BUFFER (CAT. NO. 5808)May 29, 1986
K850210sclavoISOENZYME TEST LD-1March 29, 1985
K842669helena laboratoriesTITAN GEL ISO DOT LDH KITNovember 9, 1984
K841433corning medical and scientificCORNING LACTATE DEHYDROPHORETIC ASSAYMay 16, 1984
K832314em industriesCARDIZYME PLUS LD #65094/93September 1, 1983
K830872helena laboratoriesTITAN GEL LDH ISO-ENZYME CONTROLApril 12, 1983
K802628beckman instrumentsPARAGON ELECTROPHORESIS LACTATE REAG.KITDecember 11, 1980