LCDClass II

Enzyme Immunoassay, Gentamicin

21 CFR 862.3450 / Clinical Toxicology

LCD is the FDA product code for Enzyme Immunoassay, Gentamicin, a class II device type, regulated under 21 CFR 862.3450. As of 2026-09-10, FDA records hold 37 510(k) clearances under this code, the most recent dated 2025-07-09, and 13 recalls.

Classification record

Product code: LCD
Device name: Enzyme Immunoassay, Gentamicin
Regulation: 21 CFR 862.3450
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: 37
Ingested recalls: 13

Clearances, product code LCD

By decision year

37 clearances under product code LCD with a decision year between 1980 and 2025, 1983 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code LCD by decision year
Year	Clearances
1980	1
1981	2
1982	1
1983	4
1985	2
1986	3
1987	4
1989	2
1990	3
1991	1
1994	2
1995	2
1996	2
2001	3
2002	1
2005	1
2006	1
2011	1
2025	1

Applicants with the most clearances

Product code LCD

Applicants holding the most 510(k) clearances under product code LCD
Applicant	Clearances
Syva Co.	4
Syva Co.	4
E.I. Dupont de Nemours & Co., Inc.	3
Abbott Medical	2
Siemens Healthcare Diagnostics Inc.	2
Instrumentation Laboratory Co.	2
Seradyn, Inc.	2
Technicon Instruments Corp.	2
Abbott Mfg., Inc.	1
American Dade	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order