KLTClass II

Enzyme Immunoassay, Carbamazepine

21 CFR 862.3645 / Clinical Toxicology

KLT is the FDA product code for Enzyme Immunoassay, Carbamazepine, a class II device type, regulated under 21 CFR 862.3645. As of 2026-09-10, FDA records hold 56 510(k) clearances under this code, the most recent dated 2015-10-22, and 5 recalls.

Classification record

Product code: KLT
Device name: Enzyme Immunoassay, Carbamazepine
Regulation: 21 CFR 862.3645
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: 56
Ingested recalls: 5

Clearances, product code KLT

By decision year

56 clearances under product code KLT with a decision year between 1978 and 2015, 1987 the highest year at 6.

Show the numbers

510(k) clearances under FDA product code KLT by decision year
Year	Clearances
1978	1
1979	2
1980	1
1981	1
1982	2
1983	5
1984	1
1985	2
1986	1
1987	6
1988	1
1989	2
1990	3
1991	1
1992	2
1993	2
1994	2
1995	2
1996	3
1997	3
1998	1
2000	4
2001	1
2002	1
2003	1
2005	1
2007	1
2011	1
2013	1
2015	1

Applicants with the most clearances

Product code KLT

Applicants holding the most 510(k) clearances under product code KLT
Applicant	Clearances
Syva Co.	6
Abbott Medical	5
Syva Co.	4
Beckman Instruments, Inc.	3
Miles Laboratories, Inc.	3
Bayer Corp.	2
Instrumentation Laboratory Co.	2
Microgenics Corporation	2
Roche Diagnostic Systems, Inc.	2
Syva Co.	2

Companies listing this code with FDA

Companies whose registered establishments list this code