CFJ · Class II · 21 CFR 862.1440

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

Leading manufacturers include Em Diagnostic Systems, Inc., Harleco and Beckman Instruments, Inc..

111
Total
111
Cleared
44d
Avg days
1976
Since

FDA 510(k) Cleared Nad Reduction/nadh Oxidation, Lactate Dehydrogenase Devices (Product Code CFJ)

111 devices
1–24 of 111
Cleared Oct 02, 2013
ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT
K131975
Alfa Wassermann Diagnostic Technologies, Inc.
Chemistry · 96d
Cleared Sep 09, 2009
S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017
K091544
Alfa Wassermann, Inc.
Chemistry · 105d
Cleared Jul 08, 2005
PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM
K051108
Abaxis, Inc.
Chemistry · 67d
Cleared Jan 22, 1998
LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30
K974859
Diagnostic Chemicals , Ltd.
Chemistry · 24d
Cleared Oct 08, 1997
LIQUID LDH-L REAGENT SET
K973589
Pointe Scientific, Inc.,
Chemistry · 16d
Cleared May 07, 1997
LACTATE DEHYDROGENASE (LD)
K970684
Randox Laboratories, Ltd.
Chemistry · 72d
Cleared May 02, 1997
LD-L REAGENT
K971398
Carolina Liquid Chemistries Corp.
Chemistry · 17d
Cleared Jan 09, 1997
LACTATE DEHYDROGENASE
K964912
Derma Media Lab., Inc.
Chemistry · 31d
Cleared Jun 03, 1996
LACTATE DEHYDROGENASE REAGENT SET
K961431
Pointe Scientific, Inc.,
Chemistry · 49d
Cleared Aug 07, 1995
LACTATE DEHYDROGENASE REAGENT SYSTEM
K952747
Medical Diagnostic Technologies, Inc.
Chemistry · 52d
Cleared Feb 23, 1995
HICHEM LDH/L REAGENT KIT
K946022
Hichem Diagnostics
Chemistry · 73d
Cleared Dec 29, 1994
LACTATE DEHYDROGENASE QVET
K942964
Prisma Systems
Chemistry · 189d
Cleared Dec 16, 1993
LACTATE DEHYDROGENASE (LD)
K935175
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Feb 05, 1993
LACTATE DEHYDROGENASE (LD) TEST ITEM #65418
K924703
Em Diagnostic Systems, Inc.
Chemistry · 141d
Cleared Nov 16, 1992
OLYMPUS LACTATE DEHYDROGENASE REAGENT
K924965
Olympus Corp.
Chemistry · 47d
Cleared Sep 18, 1992
OLYMPUS LACTATE DEHYDROGENASE REAGENT
K923412
Olympus Corp.
Chemistry · 70d
Cleared Mar 23, 1992
SYNERMED LDHH-L REAGENT KIT
K921025
Synermed, Inc.
Chemistry · 20d
Cleared Mar 18, 1992
DMA LD KINETIC PROCEDURE
K915803
Data Medical Associates, Inc.
Chemistry · 85d
Cleared Oct 11, 1991
ABBOTT QUICKSTART LDH,#5A31
K914262
Em Diagnostic Systems, Inc.
Chemistry · 18d
Cleared Apr 12, 1991
SYSTEMATE LACTATE DEHYDROGENASE (EPOS APPL) #65476
K910640
Em Diagnostic Systems, Inc.
Chemistry · 58d
Cleared Mar 11, 1991
BIOTROL LACTATE DEHYDROGENASE (L-P)
K905683
Biotrol, USA, Inc.
Chemistry · 82d
Cleared Oct 12, 1990
SYNERMED LDH REAGENT KIT
K903773
Synermed, Inc.
Chemistry · 53d
Cleared Apr 19, 1990
AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711
K900667
American Research Products Co.
Chemistry · 65d
Cleared Mar 30, 1990
ROCHE REAGENT FOR LDH
K900121
Roche Diagnostic Systems, Inc.
Chemistry · 80d

About Product Code CFJ - Regulatory Context