CFE · Class II · 21 CFR 862.1445

FDA Product Code CFE: Electrophoretic, Lactate Dehydrogenase Isoenzymes

Leading manufacturers include Helena Laboratories, Corning Medical & Scientific and Electrophoresis Corp. of America.

28
Total
28
Cleared
58d
Avg days
1978
Since

FDA 510(k) Cleared Electrophoretic, Lactate Dehydrogenase Isoenzymes Devices (Product Code CFE)

28 devices
1–24 of 28
Cleared Aug 31, 2010
GELSCAN, MODEL 1206
K100307
Sebia
Chemistry · 209d
Cleared Oct 01, 2002
SPIFE LD-12 KIT, MODEL 3338
K022455
Helena Laboratories
Chemistry · 67d
Cleared Mar 29, 2002
SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452
K020467
Helena Laboratories
Chemistry · 45d
Cleared Mar 10, 1997
HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT
K970477
Sebia
Chemistry · 31d
Cleared Aug 17, 1994
CARDIO REP LD
K940224
Helena Laboratories
Chemistry · 211d
Cleared Apr 29, 1992
ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD
K921455
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 33d
Cleared Feb 06, 1991
ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1 (LD1) METH
K905861
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 37d
Cleared Aug 31, 1989
ROCHO ISOMUNE - LD
K894081
Roche Diagnostic Systems, Inc.
Chemistry · 84d
Cleared Jun 20, 1989
REP(TM) LD-2 STAT KIT, CAT. NO. 3078
K892818
Helena Laboratories
Chemistry · 64d
Cleared Nov 24, 1987
TITAN GEL REP LDH-30 HV
K874142
Helena Laboratories
Chemistry · 42d
Cleared Nov 24, 1987
TITAN GEL REP LDH-6 HV
K874145
Helena Laboratories
Chemistry · 42d
Cleared Nov 23, 1987
TITAN GEL REP LDH-12 HV
K874143
Helena Laboratories
Chemistry · 41d
Cleared Oct 20, 1987
TITAN GEL LDH REP SYSTEM
K873386
Helena Laboratories
Chemistry · 57d
Cleared May 29, 1986
CK/LD BUFFER (CAT. NO. 5808)
K861750
Helena Laboratories
Chemistry · 23d
Cleared Mar 29, 1985
ISOENZYME TEST LD-1
K850210
Sclavo, Inc.
Chemistry · 73d
Cleared Nov 09, 1984
TITAN GEL ISO DOT LDH KIT
K842669
Helena Laboratories
Chemistry · 122d
Cleared May 16, 1984
CORNING LACTATE DEHYDROPHORETIC ASSAY
K841433
Corning Medical & Scientific
Chemistry · 40d
Cleared Apr 12, 1983
TITAN GEL LDH ISO-ENZYME CONTROL
K830872
Helena Laboratories
Chemistry · 25d
Cleared Dec 11, 1980
PARAGON ELECTROPHORESIS LACTATE REAG.KIT
K802628
Beckman Instruments, Inc.
Chemistry · 49d
Cleared Apr 04, 1980
TRANSPHOR TM LD LACTATE DEHYDROGENASE
K800568
Corning Medical & Scientific
Chemistry · 22d
Cleared Oct 26, 1979
ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS
K791373
Hoffmann-La Roche, Inc.
Chemistry · 94d
Cleared Oct 01, 1979
LDH CLINI GEL KIT
K791827
Clinical Sciences, Inc.
Chemistry · 14d
Cleared Sep 17, 1979
ENZYME STABILIZING REAGENT (ESR)
K791656
Electrophoresis Corp. of America
Chemistry · 27d
Cleared Sep 17, 1979
LDH ISOENZYME REAGENT
K791657
Electrophoresis Corp. of America
Chemistry · 27d

About Product Code CFE - Regulatory Context