JLWClass II

Radioimmunoassay, Thyroid-Stimulating Hormone

21 CFR 862.1690 / Clinical Chemistry

JLW is the FDA product code for Radioimmunoassay, Thyroid-Stimulating Hormone, a class II device type, regulated under 21 CFR 862.1690. As of 2026-09-10, FDA records hold 242 510(k) clearances under this code, the most recent dated 2026-02-06, and 46 recalls.

Classification record

Product code: JLW
Device name: Radioimmunoassay, Thyroid-Stimulating Hormone
Regulation: 21 CFR 862.1690
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: 242
Ingested recalls: 46

Clearances, product code JLW

By decision year

242 clearances under product code JLW with a decision year between 1976 and 2026, 1987 the highest year at 16.

Show the numbers

510(k) clearances under FDA product code JLW by decision year
Year	Clearances
1976	4
1977	11
1978	9
1979	9
1980	5
1981	7
1982	8
1983	10
1984	9
1985	11
1986	15
1987	16
1988	7
1989	5
1990	11
1991	11
1992	12
1993	6
1994	8
1995	8
1996	8
1997	4
1998	4
1999	3
2000	2
2001	3
2002	2
2003	1
2004	2
2006	3
2008	5
2009	2
2010	1
2012	1
2013	1
2014	1
2015	3
2016	3
2017	4
2019	1
2022	1
2023	1
2024	2
2025	1
2026	1

Applicants with the most clearances

Product code JLW

Applicants holding the most 510(k) clearances under product code JLW
Applicant	Clearances
Siemens Healthcare Diagnostics Inc.	23
Abbott Medical	10
BD Becton Dickinson Vacutainer Systems Preanalytic	9
Bio-Rad	9
Micromedic Systems	8
Corning Medical & Scientific	7
Amersham Corp.	5
Ciba Corning Diagnostics Corp.	4
Hybritech, Inc.	4
Ventrex Laboratories, Inc.	4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 57 companies shown, in name order