CFJ · Class II · 21 CFR 862.1440

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

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

111
Total
111
Cleared
44d
Avg days
1976
Since
111 devices
49–72 of 111
Cleared Feb 06, 1986
LDH (OPTIMIZED) REAGENT
K860029
Sigma Chemical Co.
Chemistry · 31d
Cleared Jan 21, 1986
LACTIC DEHYDROGENASE (VV) REAGENT SET
K855157
Technostics Intl.
Chemistry · 26d
Cleared Jan 14, 1986
LACTIC DEHYDROGENASE REAGENT SET
K855159
Technostics Intl.
Chemistry · 19d
Cleared Dec 05, 1985
ULTRAZYME PLUS & SYSTEMATE LDH
K854585
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Aug 07, 1985
AMRESCO SUBST CONCEN, PRO #2432,BUF,NAD,2455,TRI
K852948
Amresco, Inc.
Chemistry · 27d
Cleared May 31, 1985
LD-L REAGENT
K851996
Alpkem Corp.
Chemistry · 24d
Cleared May 30, 1985
LD-P REAGENT
K851997
Alpkem Corp.
Chemistry · 23d
Cleared Mar 01, 1985
LDH REAGENT FOR DEMAND ANALYZER
K850378
Advanced Biomedical Methods, Inc.
Chemistry · 29d
Cleared Sep 13, 1984
SYSTEMATE LDH, 67210
K843269
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Jul 20, 1984
LACTATE DEHYDROGENASE ASSAY KIT
K842507
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 24d
Cleared Jul 18, 1984
LACTATE DENYDRO GENASE ASSAY KIT
K842244
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 43d
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 Jul 20, 1982
LDH-UV REAGENT SET
K821201
Omega Medical Electronics
Chemistry · 84d
Cleared Jul 14, 1982
ULTRAZYME PLUS LDH
K821878
Harleco Diagnostics
Chemistry · 19d
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