CFJ · Class II · 21 CFR 862.1440

FDA Product Code CFJ: Nad Reduction/nadh Oxidation, Lactate Dehydrogenase

Leading manufacturers include Em Diagnostic Systems, Inc., J.T. Baker Chemical Co. and Harleco.

111
Total
111
Cleared
44d
Avg days
1976
Since
111 devices
73–96 of 111
Cleared Dec 31, 1981
LDH-L
K813496
Pointe Scientific, Inc.,
Chemistry · 17d
Cleared Sep 24, 1981
ULTRA ZYME PLUS LDH #64950, 65038 & 39
K812590
Harleco
Chemistry · 13d
Cleared Sep 14, 1981
SPIN-CHEM LD-L REAGENT
K812472
Smithkline Diagnostics, Inc.
Chemistry · 14d
Cleared Jan 28, 1981
LDH-L LIQUID ENZYMATIC, KINETIC KIT
K810083
Bio-Analytics Laboratories, Inc.
Chemistry · 15d
Cleared Dec 22, 1980
SERALYZER LDH REAGENT STRIPS, CALIBR
K803019
Miles Laboratories, Inc.
Chemistry · 24d
Cleared Nov 12, 1980
BECKMAN LIQUID-STAT LD-L-UV ENZYME
K802572
Beckman Instruments, Inc.
Chemistry · 26d
Cleared May 28, 1980
REAGENT FOR DETERM. LACTATE/DEHYDROGENAS
K800691
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared Feb 13, 1980
LDH (L-P) REAGENT
K800120
Gilford Diagnostics
Chemistry · 26d
Cleared Jan 17, 1980
COBAS-BLO REAGENTS (LACTATE DEHYDRO
K792658
Hoffmann-La Roche, Inc.
Chemistry · 22d
Cleared Jul 17, 1979
SPIN CHEM REAGENT, DETERMINATION OF LDH-
K791081
Smithkline Diagnostics, Inc.
Chemistry · 35d
Cleared Jul 17, 1979
PLUS CHEM, DETERMINATION OF LD (LDH-P)
K791085
Smithkline Diagnostics, Inc.
Chemistry · 35d
Cleared May 15, 1979
LD-P REAGENT (LDH P-L REAGENT)
K790771
Gilford Diagnostics
Chemistry · 25d
Cleared Apr 04, 1979
NICOTINAMIDE-ADENINE AINUCLEOTIDE (NAD)
K790248
Boehringer Laboratories
Chemistry · 55d
Cleared Feb 08, 1979
SERUM, LACTIC DEHYDROGENASE
K790020
Fisher Scientific Co., LLC
Chemistry · 36d
Cleared Nov 22, 1978
LDH REAGENT SYSTEM
K781765
American Monitor Corp.
Chemistry · 37d
Cleared Nov 22, 1978
LDH
K781775
Gilford Diagnostics
Chemistry · 40d
Cleared Nov 03, 1978
NAD REDUCTION METHOD, LACTATE PYRIVATE
K781724
Medical Analysis Systems, Inc.
Chemistry · 23d
Cleared Oct 03, 1978
SINGLE VIAL LDH-L TRIS
K781538
Boehringer Mannheim Corp.
Chemistry · 25d
Cleared Aug 10, 1978
LDH (UV KINETIC)
K781128
Macomb Chemical Co.
Chemistry · 41d
Cleared Apr 18, 1978
SINGLE VIAL LACTATE
K780563
Boehringer Mannheim Corp.
Hematology · 11d
Cleared Feb 14, 1978
ULTRAZYME PLUS LDH
K780101
Harleco
Chemistry · 25d
Cleared Feb 01, 1978
LACTATE DEHYDROGENASE
K780041
Beckman Instruments, Inc.
Chemistry · 23d
Cleared Nov 22, 1977
LACTATE DEHYDROGENASE
K771836
Gamma Enterprises, Inc.
Chemistry · 62d
Cleared Nov 15, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS LDH
K772028
Harleco
Chemistry · 19d