CFE · Class II · 21 CFR 862.1445

FDA Product Code CFE: Electrophoretic, Lactate Dehydrogenase Isoenzymes

Leading manufacturers include Helena Laboratories, Corning Medical & Scientific and E.I. Dupont DE Nemours & Co., Inc..

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 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 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 Feb 07, 1978
LACTATE DEHYDROGENASE COLORIMETRIC SUB.
K780080
Corning Medical & Scientific
Chemistry · 22d

About Product Code CFE - Regulatory Context