CGAClass II

Glucose Oxidase, Glucose

21 CFR 862.1345 / Clinical Chemistry

CGA is the FDA product code for Glucose Oxidase, Glucose, a class II device type, regulated under 21 CFR 862.1345. As of 2026-09-10, FDA records hold 401 510(k) clearances under this code, the most recent dated 2026-05-01, and 89 recalls.

Classification record

Product code: CGA
Device name: Glucose Oxidase, Glucose
Regulation: 21 CFR 862.1345
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: 401
Ingested recalls: 89

Clearances, product code CGA

By decision year

401 clearances under product code CGA with a decision year between 1976 and 2026, 1986 the highest year at 17.

Show the numbers

510(k) clearances under FDA product code CGA by decision year
Year	Clearances
1976	4
1977	9
1978	7
1979	7
1980	9
1981	14
1982	13
1983	10
1984	13
1985	12
1986	17
1987	15
1988	8
1989	17
1990	9
1991	11
1992	15
1993	12
1994	4
1995	14
1996	12
1997	13
1998	7
1999	15
2000	9
2001	10
2002	9
2003	5
2004	6
2005	7
2006	5
2007	7
2008	6
2009	10
2010	8
2011	9
2012	10
2013	3
2014	5
2015	4
2016	4
2017	2
2018	2
2019	2
2020	2
2021	1
2022	1
2023	4
2024	2
2026	1

Applicants with the most clearances

Product code CGA

Applicants holding the most 510(k) clearances under product code CGA
Applicant	Clearances
Lifescan, Inc.	21
Boehringer Mannheim Corp.	17
Apex Biotechnology Corp.	14
Miles Laboratories, Inc.	12
Medisense, Inc.	11
Kulzer GmbH	10
Taidoc Technology Corporation	10
Abbott Medical	9
Home Diagnostics, Inc.	9
Arkray Factory USA, Inc.	9

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 120 companies shown, in name order