CEPClass I

Radioimmunoassay, Luteinizing Hormone

21 CFR 862.1485 / Clinical Chemistry

CEP is the FDA product code for Radioimmunoassay, Luteinizing Hormone, a class I device type, regulated under 21 CFR 862.1485. As of 2026-09-10, FDA records hold 143 510(k) clearances under this code, the most recent dated 2003-01-16, and 6 recalls.

Classification record

Product code: CEP
Device name: Radioimmunoassay, Luteinizing Hormone
Regulation: 21 CFR 862.1485
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: 143
Ingested recalls: 6

Clearances, product code CEP

By decision year

143 clearances under product code CEP with a decision year between 1977 and 2003, 1987 the highest year at 15.

Show the numbers

510(k) clearances under FDA product code CEP by decision year
Year	Clearances
1977	1
1978	3
1979	2
1980	2
1981	8
1982	8
1983	1
1984	7
1985	8
1986	13
1987	15
1988	9
1989	7
1990	10
1991	5
1992	5
1993	4
1994	6
1995	5
1996	5
1997	5
1998	3
1999	3
2000	1
2001	3
2002	3
2003	1

Applicants with the most clearances

Product code CEP

Applicants holding the most 510(k) clearances under product code CEP
Applicant	Clearances
Siemens Healthcare Diagnostics Inc.	5
Amersham Corp.	4
Leeco Diagnostics, Inc.	4
Monoclonal Antibodies, Inc.	4
Nichols Institute Diagnostics	4
Pcl-Ria, Inc.	4
Unipath, Ltd.	4
Armkel, LLC	3
Bio-Rad	3
Ciba Corning Diagnostics Corp.	3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 71 companies shown, in name order