CITClass II

Nadh Oxidation/Nad Reduction, Ast/Sgot

21 CFR 862.1100 / Clinical Chemistry

CIT is the FDA product code for Nadh Oxidation/Nad Reduction, Ast/Sgot, a class II device type, regulated under 21 CFR 862.1100. As of 2026-09-10, FDA records hold 139 510(k) clearances under this code, the most recent dated 2010-09-20, and 13 recalls.

Classification record

Product code: CIT
Device name: Nadh Oxidation/Nad Reduction, Ast/Sgot
Regulation: 21 CFR 862.1100
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: 139
Ingested recalls: 13

Clearances, product code CIT

By decision year

139 clearances under product code CIT with a decision year between 1976 and 2010, 1986 the highest year at 11.

Show the numbers

510(k) clearances under FDA product code CIT by decision year
Year	Clearances
1976	2
1977	3
1978	9
1979	7
1980	6
1981	6
1982	6
1983	1
1984	7
1985	5
1986	11
1987	7
1988	5
1989	6
1990	8
1991	3
1992	8
1993	3
1994	4
1995	2
1996	3
1997	3
1998	8
1999	5
2000	1
2001	3
2002	1
2006	1
2007	2
2008	2
2010	1

Applicants with the most clearances

Product code CIT

Applicants holding the most 510(k) clearances under product code CIT
Applicant	Clearances
Em Diagnostic Systems, Inc.	10
Abbott Medical	8
Roche Diagnostic Systems, Inc.	6
American Monitor Corp.	5
Coulter Electronics, Inc.	4
Sigma Diagnostics, Inc.	4
Trace Scientific, Ltd.	4
Amresco, Inc.	3
Boehringer Mannheim Corp.	3
Data Medical Associates, Inc.	3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 39 companies shown, in name order