CFE · Class II · 21 CFR 862.1445

FDA Product Code CFE: Electrophoretic, Lactate Dehydrogenase Isoenzymes

Leading manufacturers include Helena Laboratories, E.I. Dupont DE Nemours & Co., Inc. and Beckman Instruments, 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 Nov 09, 1984
TITAN GEL ISO DOT LDH KIT
K842669
Helena Laboratories
Chemistry · 122d
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

About Product Code CFE - Regulatory Context