CKAClass I

Nadh Oxidation/Nad Reduction, Alt/Sgpt

21 CFR 862.1030 / Clinical Chemistry

CKA is the FDA product code for Nadh Oxidation/Nad Reduction, Alt/Sgpt, a class I device type, regulated under 21 CFR 862.1030. As of 2026-09-10, FDA records hold 127 510(k) clearances under this code, the most recent dated 2013-06-07, and 18 recalls.

Classification record

Product code: CKA
Device name: Nadh Oxidation/Nad Reduction, Alt/Sgpt
Regulation: 21 CFR 862.1030
Device class: Class I
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: 127
Ingested recalls: 18

Clearances, product code CKA

By decision year

127 clearances under product code CKA with a decision year between 1976 and 2013, 1986 the highest year at 14.

Show the numbers

510(k) clearances under FDA product code CKA by decision year
Year	Clearances
1976	2
1977	7
1978	7
1979	5
1980	5
1981	5
1982	9
1983	2
1984	6
1985	6
1986	14
1987	6
1988	6
1989	9
1990	6
1991	3
1992	8
1993	2
1994	5
1995	4
1996	1
1997	3
1998	2
2002	1
2006	1
2012	1
2013	1

Applicants with the most clearances

Product code CKA

Applicants holding the most 510(k) clearances under product code CKA
Applicant	Clearances
Em Diagnostic Systems, Inc.	10
Boehringer Mannheim Corp.	5
American Monitor Corp.	4
Beckman Instruments, Inc.	4
Coulter Electronics, Inc.	4
Harleco	4
Technicon Instruments Corp.	4
Trace Scientific, Ltd.	4
Abbott Medical	3
Data Medical Associates, Inc.	3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 37 companies shown, in name order