CGNClass II

Acid, Folic, Radioimmunoassay

21 CFR 862.1295 / Clinical Chemistry

CGN is the FDA product code for Acid, Folic, Radioimmunoassay, a class II device type, regulated under 21 CFR 862.1295. As of 2026-09-10, FDA records hold 64 510(k) clearances under this code, the most recent dated 2024-06-17, and 28 recalls.

Classification record

Product code: CGN
Device name: Acid, Folic, Radioimmunoassay
Regulation: 21 CFR 862.1295
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: 64
Ingested recalls: 28

Clearances, product code CGN

By decision year

64 clearances under product code CGN with a decision year between 1976 and 2024, 1995 the highest year at 5.

Show the numbers

510(k) clearances under FDA product code CGN by decision year
Year	Clearances
1976	3
1977	1
1978	3
1979	2
1980	3
1981	4
1982	1
1983	1
1984	1
1989	1
1992	4
1993	3
1994	4
1995	5
1996	4
1997	1
1998	1
1999	5
2000	1
2001	1
2002	1
2003	1
2004	1
2005	1
2006	1
2009	2
2010	1
2011	1
2014	1
2016	1
2018	1
2020	1
2023	1
2024	1

Applicants with the most clearances

Product code CGN

Applicants holding the most 510(k) clearances under product code CGN
Applicant	Clearances
Siemens Healthcare Diagnostics Inc.	10
Roche Diagnostics GmbH	7
Abbott Medical	5
Bio-Rad	5
Clinical Assays, Inc.	3
Microgenics Corporation	3
Amersham Corp.	2
BD Becton Dickinson Vacutainer Systems Preanalytic	2
Ciba Corning Diagnostics Corp.	2
Ortho-Clinical Diagnostics, Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 24 companies shown, in name order