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 Boehringer Mannheim Corp..

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 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 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 30, 1990
ROCHE REAGENT FOR LDH
K900121
Roche Diagnostic Systems, Inc.
Chemistry · 80d
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 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 Feb 06, 1986
LDH (OPTIMIZED) REAGENT
K860029
Sigma Chemical Co.
Chemistry · 31d
Cleared Dec 05, 1985
ULTRAZYME PLUS & SYSTEMATE LDH
K854585
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Sep 13, 1984
SYSTEMATE LDH, 67210
K843269
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Jun 08, 1984
TDX REA LDH
K841703
Abbott Laboratories
Chemistry · 46d
Cleared Jul 19, 1983
ASTRA SYSTEMS ENZYME MODULE LD-P
K832048
Beckman Instruments, Inc.
Chemistry · 25d
Cleared Jun 08, 1983
ASTRA SYSTEMS ENZYME MODULE
K831353
Beckman Instruments, Inc.
Chemistry · 43d
Cleared Mar 08, 1982
LD-L TRIS SYSTEM PACK TEST
K820378
Boehringer Mannheim Corp.
Chemistry · 27d
Cleared Nov 12, 1980
BECKMAN LIQUID-STAT LD-L-UV ENZYME
K802572
Beckman Instruments, Inc.
Chemistry · 26d
Cleared Oct 03, 1978
SINGLE VIAL LDH-L TRIS
K781538
Boehringer Mannheim Corp.
Chemistry · 25d
Cleared Apr 18, 1978
SINGLE VIAL LACTATE
K780563
Boehringer Mannheim Corp.
Hematology · 11d
Cleared Feb 01, 1978
LACTATE DEHYDROGENASE
K780041
Beckman Instruments, Inc.
Chemistry · 23d
Cleared Sep 02, 1977
MULTISTAT III LACTIC DEHYDROGENASE
K771465
Instrumentation Laboratory CO
Chemistry · 29d

About Product Code CFJ - Regulatory Context