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

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 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
Cleared Mar 09, 1990
COULTER LD (LDH-L) REAGENT
K897164
Coulter Electronics, Inc.
Chemistry · 71d

About Product Code CFJ - Regulatory Context