KLIClass II

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

21 CFR 862.1700 / Clinical Chemistry

KLI is the FDA product code for Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine, a class II device type, regulated under 21 CFR 862.1700. As of 2026-09-10, FDA records hold 86 510(k) clearances under this code, the most recent dated 2016-10-18, and 12 recalls.

Classification record

Product code: KLI
Device name: Enzyme Immunoassay, Non-Radiolabeled, 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: 86
Ingested recalls: 12

Clearances, product code KLI

By decision year

86 clearances under product code KLI with a decision year between 1977 and 2016, 1989 the highest year at 7.

Show the numbers

510(k) clearances under FDA product code KLI by decision year
Year	Clearances
1977	1
1978	1
1979	3
1980	4
1981	1
1982	2
1983	4
1984	6
1985	1
1986	2
1987	4
1988	5
1989	7
1990	6
1991	4
1992	3
1993	2
1994	6
1995	5
1996	3
1997	4
1998	2
1999	2
2000	2
2002	1
2003	1
2009	1
2011	1
2013	1
2016	1

Applicants with the most clearances

Product code KLI

Applicants holding the most 510(k) clearances under product code KLI
Applicant	Clearances
Syva Co.	7
Microgenics Corporation	6
Abbott Medical	4
Syva Co.	4
Technicon Instruments Corp.	4
Siemens Healthcare Diagnostics Inc.	3
Bio-Rad	2
Biocircuits Corp.	2
Biotecx Laboratories, Inc.	2
Ciba Corning Diagnostics Corp.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 34 companies shown, in name order