LFGClass II

Radioimmunoassay, Tricyclic Antidepressant Drugs

21 CFR 862.3910 / Clinical Toxicology

LFG is the FDA product code for Radioimmunoassay, Tricyclic Antidepressant Drugs, a class II device type, regulated under 21 CFR 862.3910. FDA's definition for this code reads: "Intended to measure any of the tricyclic antidepressant drugs in serum or urine". As of 2026-09-10, FDA records hold 21 510(k) clearances under this code, the most recent dated 2015-08-18, and 2 recalls.

Classification record

Product code: LFG
Device name: Radioimmunoassay, Tricyclic Antidepressant Drugs
FDA definition: Intended to measure any of the tricyclic antidepressant drugs in serum or urine.
Regulation: 21 CFR 862.3910
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: 21
Ingested recalls: 2

Clearances, product code LFG

By decision year

21 clearances under product code LFG with a decision year between 1982 and 2015, 1985 the highest year at 5.

Show the numbers

510(k) clearances under FDA product code LFG by decision year
Year	Clearances
1982	3
1983	1
1984	2
1985	5
1986	1
1987	1
1998	1
2001	1
2002	1
2006	1
2007	1
2011	1
2014	1
2015	1

Applicants with the most clearances

Product code LFG

Applicants holding the most 510(k) clearances under product code LFG
Applicant	Clearances
Syva Co.	6
Syva Co.	3
Guangzhou Wondfo Biotech Co., Ltd.	2
Ucp Biosciences, Inc.	2
Wien Laboratories, Inc.	2
Acon Laboratories, Inc.	1
Abbott Medical	1
E.I. Dupont de Nemours & Co., Inc.	1
Healgen Scientific LLC	1
MEDTOX Diagnostics, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 47 companies shown, in name order