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
49–72 of 111
Cleared Jun 14, 1984
SIGMS PROCED. 228 UV LACTATE DEHYDRO
K841917
Sigma Diagnostics, Inc.
Chemistry · 36d
Cleared Jun 08, 1984
TDX REA LDH
K841703
Abbott Laboratories
Chemistry · 46d
Cleared May 01, 1984
LDH-UV REAGENT SET
K841058
Medical Specialties, Inc.
Chemistry · 50d
Cleared Mar 23, 1984
KINETIC LDH, A< BLUE 610 METHOD
K840006
American Monitor Corp.
Chemistry · 79d
Cleared Jul 19, 1983
ASTRA SYSTEMS ENZYME MODULE LD-P
K832048
Beckman Instruments, Inc.
Chemistry · 25d
Cleared Jun 16, 1983
RAICHEM LDH-P REAGENT W/SEPARATE START-
K831419
Reagents Applications, Inc.
Chemistry · 44d
Cleared Jun 08, 1983
ASTRA SYSTEMS ENZYME MODULE
K831353
Beckman Instruments, Inc.
Chemistry · 43d
Cleared Jan 09, 1983
FLOW-PAC LDH REAGENT SET
K823721
Amresco, Inc.
Chemistry · 30d
Cleared Aug 27, 1982
RAICHEM LDH-L REAGENT
K822312
Reagents Applications, Inc.
Chemistry · 24d
Cleared Jun 01, 1982
ULTRAZYME PLUS LDH, #64950,65038&65039
K821466
Emd Chemicals, Inc.
Chemistry · 14d
Cleared Mar 08, 1982
LD-L TRIS SYSTEM PACK TEST
K820378
Boehringer Mannheim Corp.
Chemistry · 27d
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 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 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