CDXClass II

Radioimmunoassay, Total Thyroxine

21 CFR 862.1700 / Clinical Chemistry

CDX is the FDA product code for Radioimmunoassay, Total Thyroxine, a class II device type, regulated under 21 CFR 862.1700. As of 2026-09-10, FDA records hold 121 510(k) clearances under this code, the most recent dated 1996-06-13, and one recall.

Classification record

Product code: CDX
Device name: Radioimmunoassay, Total Thyroxine
Regulation: 21 CFR 862.1700
Device class: Class II
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: 121
Ingested recalls: 1

Clearances, product code CDX

By decision year

121 clearances under product code CDX with a decision year between 1976 and 1996, 1977 the highest year at 19.

Show the numbers

510(k) clearances under FDA product code CDX by decision year
Year	Clearances
1976	5
1977	19
1978	18
1979	12
1980	10
1981	5
1982	9
1983	4
1984	4
1985	1
1986	4
1987	5
1988	3
1989	1
1990	3
1991	4
1992	4
1993	6
1994	1
1995	2
1996	1

Applicants with the most clearances

Product code CDX

Applicants holding the most 510(k) clearances under product code CDX
Applicant	Clearances
Abbott Medical	6
BD Becton Dickinson Vacutainer Systems Preanalytic	6
Bio-Rad	4
Siemens Healthcare Diagnostics Inc.	4
Micromedic Systems	4
Miles Laboratories, Inc.	4
Ciba Corning Diagnostics Corp.	3
Clinical Assays, Inc.	3
Nuclear Diagnostics, Inc.	3
Pcl-Ria, Inc.	3

Companies listing this code with FDA

Companies whose registered establishments list this code