CGJClass I

Radioimmunoassay, Follicle-Stimulating Hormone

21 CFR 862.1300 / Clinical Chemistry

CGJ is the FDA product code for Radioimmunoassay, Follicle-Stimulating Hormone, a class I device type, regulated under 21 CFR 862.1300. As of 2026-09-10, FDA records hold 88 510(k) clearances under this code, the most recent dated 2005-11-30, and 9 recalls.

Classification record

Product code: CGJ
Device name: Radioimmunoassay, Follicle-Stimulating Hormone
Regulation: 21 CFR 862.1300
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: 88
Ingested recalls: 9

Clearances, product code CGJ

By decision year

88 clearances under product code CGJ with a decision year between 1976 and 2005, 1981 the highest year at 7.

Show the numbers

510(k) clearances under FDA product code CGJ by decision year
Year	Clearances
1976	1
1977	1
1978	1
1979	2
1980	2
1981	7
1982	7
1983	1
1984	5
1985	3
1986	7
1987	5
1988	7
1989	7
1990	7
1991	4
1992	4
1993	1
1994	4
1995	1
1996	2
1997	3
2001	1
2003	1
2004	2
2005	2

Applicants with the most clearances

Product code CGJ

Applicants holding the most 510(k) clearances under product code CGJ
Applicant	Clearances
Amersham Corp.	4
Medix Biotech, Inc.	4
Abbott Medical	3
Siemens Healthcare Diagnostics Inc.	3
Nichols Institute Diagnostics	3
American Dade	2
BD Becton Dickinson Vacutainer Systems Preanalytic	2
Bio-Rad	2
Boehringer Mannheim Corp.	2
Ciba Corning Diagnostics Corp.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 45 companies shown, in name order