LCXClass II

Kit, Test, Pregnancy, Hcg, Over The Counter

21 CFR 862.1155 / Clinical Chemistry

LCX is the FDA product code for Kit, Test, Pregnancy, Hcg, Over The Counter, a class II device type, regulated under 21 CFR 862.1155. As of 2026-09-10, FDA records hold 226 510(k) clearances under this code, the most recent dated 2025-09-09, and 25 recalls.

Classification record

Product code: LCX
Device name: Kit, Test, Pregnancy, Hcg, Over The Counter
Regulation: 21 CFR 862.1155
Device class: Class II
Review panel: Clinical Chemistry
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 226
Ingested recalls: 25

Clearances, product code LCX

By decision year

226 clearances under product code LCX with a decision year between 1978 and 2025, 1996 the highest year at 18.

Show the numbers

510(k) clearances under FDA product code LCX by decision year
Year	Clearances
1978	3
1981	1
1982	2
1983	3
1984	11
1985	3
1986	6
1987	6
1988	7
1989	3
1990	3
1991	6
1992	3
1993	6
1994	7
1995	6
1996	18
1997	11
1998	6
1999	9
2000	2
2001	4
2002	3
2003	13
2004	9
2005	6
2006	7
2007	4
2009	2
2011	5
2012	1
2013	8
2015	2
2016	1
2017	1
2018	4
2019	7
2020	2
2021	2
2022	6
2023	2
2024	10
2025	5

Applicants with the most clearances

Product code LCX

Applicants holding the most 510(k) clearances under product code LCX
Applicant	Clearances
Unipath, Ltd.	20
Acon Laboratories, Inc.	10
Armkel, LLC	10
Ortho-Clinical Diagnostics, Inc.	9
Syntron Bioresearch, Inc.	6
Advanced Care Products	5
Mizuho USA, Inc.	5
Phamatech Inc.	5
Abbott Medical	4
Church & Dwight Co., Inc.	4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 113 companies shown, in name order