KLSClass II

Enzyme Immunoassay, Theophylline

21 CFR 862.3880 / Clinical Toxicology

KLS is the FDA product code for Enzyme Immunoassay, Theophylline, a class II device type, regulated under 21 CFR 862.3880. As of 2026-09-10, FDA records hold 71 510(k) clearances under this code, the most recent dated 2004-11-30, and 8 recalls.

Classification record

Product code: KLS
Device name: Enzyme Immunoassay, Theophylline
Regulation: 21 CFR 862.3880
Device class: Class II
Review panel: Clinical Toxicology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 71
Ingested recalls: 8

Clearances, product code KLS

By decision year

71 clearances under product code KLS with a decision year between 1978 and 2004, 1985 the highest year at 8.

Show the numbers

510(k) clearances under FDA product code KLS by decision year
Year	Clearances
1978	1
1979	1
1980	4
1981	3
1982	2
1983	5
1984	5
1985	8
1986	7
1987	4
1988	3
1989	3
1990	5
1991	3
1993	3
1994	1
1995	3
1996	1
1997	2
2000	1
2001	2
2002	2
2004	2

Applicants with the most clearances

Product code KLS

Applicants holding the most 510(k) clearances under product code KLS
Applicant	Clearances
Abbott Medical	7
Syva Co.	6
Siemens Healthcare Diagnostics Inc.	3
E.I. Dupont de Nemours & Co., Inc.	3
Beckman Instruments, Inc.	2
Electro-Nucleonics Laboratories, Inc.	2
Em Diagnostic Systems, Inc.	2
IMMUNOTECH s.r.o.	2
Instrumentation Laboratory Co.	2
Miles Laboratories, Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order