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
25–48 of 111
Cleared Feb 16, 1990
COBAS READY LDH REAGENT
K896241
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Sep 07, 1989
LACTATE DEHYDROGENASE TEST (LD) ITEM #65418
K894482
Em Diagnostic Systems, Inc.
Chemistry · 51d
Cleared Nov 10, 1988
LACTATE DEHYDROGENASE TEST (LD) ITEM NO. 65668
K884548
Em Diagnostic Systems, Inc.
Chemistry · 10d
Cleared Jun 01, 1988
VISION(R) LDH (LACTATE DEHYDROGENASE)
K881474
Abbott Laboratories
Chemistry · 55d
Cleared Apr 05, 1988
LDH-L REAGENT SET
K880842
Tech-Neal Scientific, Inc.
Chemistry · 39d
Cleared Feb 02, 1988
LACTATE DEHYDROGENASE CAT. # 320-68, 320-69
K875206
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 46d
Cleared Dec 18, 1987
LACTATE DEHYDROGENASE LDH-L
K874848
Tech-Co, Inc.
Chemistry · 24d
Cleared Jul 07, 1987
UNI-FAST LACTATE DEHYDROGENASE (LDH-L)
K872030
Sclavo, Inc.
Chemistry · 42d
Cleared Jun 11, 1987
MULTICHEM LDH-L REAGENT
K872010
Simmler, Inc.
Chemistry · 16d
Cleared Jun 03, 1987
ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SET
K871781
Biochemical Trade, Inc.
Chemistry · 28d
Cleared Apr 14, 1987
SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS
K870752
Miles Laboratories, Inc.
Chemistry · 48d
Cleared Mar 06, 1987
WAKO(TM) AUTOKIT LDH
K870401
Wako Chemicals USA, Inc.
Chemistry · 32d
Cleared Dec 10, 1986
LDH S.C.E.
K863068
J. D. Assoc.
Chemistry · 120d
Cleared Oct 03, 1986
LACTATE DEHYDROGENASE(LD) PROCEDURE
K863255
Data Medical Associates, Inc.
Chemistry · 39d
Cleared Sep 26, 1986
EMDS(TM) LACTIC DEHYDROGENASE TESTPACKS, #67660/95
K863477
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Sep 25, 1986
EASY-TEST LACTIC DEHYDROGENASE (LDH) # 67527/95
K863545
Em Diagnostic Systems, Inc.
Chemistry · 13d
Cleared Aug 19, 1986
KING DIAGNOSTICS LDH TEST
K862306
King Diagnostics, Inc.
Chemistry · 63d
Cleared Jul 29, 1986
LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE)
K862255
Sterling Diagnostics, Inc.
Chemistry · 46d
Cleared Jun 13, 1986
LDP REAGENT CARTRIDGE (NO. 88216)
K862027
Hi Chem, Inc.
Chemistry · 16d
Cleared May 29, 1986
LACTATE DEHYDROGENASE (LD) PROCEDURE
K861662
Data Medical Associates, Inc.
Chemistry · 29d
Cleared Apr 28, 1986
HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE
K861419
Hi Chem, Inc.
Chemistry · 13d
Cleared Apr 24, 1986
LACTATE DEHYDROGENASE (LD) FOR CONT. FLOW INSTRUM.
K860713
Catachem, Inc.
Chemistry · 57d
Cleared Apr 07, 1986
L D H-L (LACTIC DEHYDROGENASE) REAGENT
K860728
Trace Scientific , Ltd.
Chemistry · 40d
Cleared Apr 07, 1986
LDH-P (LACTIC DEHYDROGENASE) REAGENT
K860729
Trace Scientific , Ltd.
Chemistry · 40d