CFJClass II

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

21 CFR 862.1440 / Clinical Chemistry

CFJ is the FDA product code for Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase, a class II device type, regulated under 21 CFR 862.1440. As of 2026-09-10, FDA records hold 111 510(k) clearances under this code, the most recent dated 2013-10-02, and 8 recalls.

Classification record

Product code: CFJ
Device name: Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Regulation: 21 CFR 862.1440
Device class: Class II
Review panel: Clinical Chemistry
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 111
Ingested recalls: 8

Clearances, product code CFJ

By decision year

111 clearances under product code CFJ with a decision year between 1976 and 2013, 1986 the highest year at 15.

Show the numbers

510(k) clearances under FDA product code CFJ by decision year
Year	Clearances
1976	5
1977	8
1978	8
1979	5
1980	5
1981	4
1982	6
1983	5
1984	7
1985	5
1986	15
1987	6
1988	5
1989	1
1990	5
1991	3
1992	4
1993	2
1994	1
1995	2
1996	1
1997	4
1998	1
2005	1
2009	1
2013	1

Applicants with the most clearances

Product code CFJ

Applicants holding the most 510(k) clearances under product code CFJ
Applicant	Clearances
Em Diagnostic Systems, Inc.	10
Beckman Instruments, Inc.	4
Harleco	4
J.T. Baker Chemical Co.	4
Boehringer Mannheim Corp.	3
Data Medical Associates, Inc.	3
Diagnostic Chemicals, Ltd. (USA)	3
Gilford Diagnostics	3
Horiba Instruments Incorporated	3
Smithkline Diagnostics, Inc.	3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 33 companies shown, in name order