CGSClass II

Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

21 CFR 862.1215 / Clinical Chemistry

CGS is the FDA product code for Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes, a class II device type, regulated under 21 CFR 862.1215. As of 2026-09-10, FDA records hold 123 510(k) clearances under this code, the most recent dated 2020-08-11, and 10 recalls.

Classification record

Product code: CGS
Device name: Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Regulation: 21 CFR 862.1215
Device class: Class II
Review panel: Clinical Chemistry
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 123
Ingested recalls: 10

Clearances, product code CGS

By decision year

123 clearances under product code CGS with a decision year between 1977 and 2020, 1989 the highest year at 10.

Show the numbers

510(k) clearances under FDA product code CGS by decision year
Year	Clearances
1977	6
1978	8
1979	1
1980	2
1981	5
1982	7
1983	2
1984	7
1985	5
1986	8
1987	9
1988	2
1989	10
1990	7
1991	2
1992	5
1993	6
1994	2
1995	4
1996	1
1997	3
1998	4
1999	2
2000	1
2001	1
2002	2
2004	1
2006	1
2007	1
2008	2
2009	1
2011	1
2013	1
2016	1
2019	1
2020	1

Applicants with the most clearances

Product code CGS

Applicants holding the most 510(k) clearances under product code CGS
Applicant	Clearances
Em Diagnostic Systems, Inc.	14
Helena Laboratories, Corp.	7
Harleco	6
Abbott Medical	4
Sekisui Diagnostics P.E.I. Inc.	3
EMD Millipore Corporation	3
Randox Laboratories, Limited	3
Reagents Applications, Inc.	3
Sclavo, Inc.	3
Siemens Healthcare Diagnostics Inc.	3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 22 companies shown, in name order