LCPClass II

Assay, Glycosylated Hemoglobin

21 CFR 864.7470 / Hematology

LCP is the FDA product code for Assay, Glycosylated Hemoglobin, a class II device type, regulated under 21 CFR 864.7470. As of 2026-09-10, FDA records hold 249 510(k) clearances under this code, the most recent dated 2024-11-22, and 103 recalls.

Classification record

Product code: LCP
Device name: Assay, Glycosylated Hemoglobin
Regulation: 21 CFR 864.7470
Device class: Class II
Review panel: Hematology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 249
Ingested recalls: 103

Clearances, product code LCP

By decision year

249 clearances under product code LCP with a decision year between 1978 and 2024, 2011 the highest year at 10.

Show the numbers

510(k) clearances under FDA product code LCP by decision year
Year	Clearances
1978	4
1979	9
1980	8
1981	9
1982	5
1983	7
1984	4
1985	3
1986	4
1987	5
1988	9
1989	7
1990	7
1991	6
1992	7
1993	5
1994	6
1995	4
1996	3
1997	5
1998	7
1999	9
2000	8
2001	6
2002	7
2003	8
2004	8
2005	5
2006	5
2007	7
2008	5
2009	6
2010	2
2011	10
2012	9
2013	2
2014	8
2015	3
2016	2
2017	5
2018	2
2019	4
2020	1
2023	2
2024	1

Applicants with the most clearances

Product code LCP

Applicants holding the most 510(k) clearances under product code LCP
Applicant	Clearances
Helena Laboratories, Corp.	19
Bio-Rad	15
Siemens Healthcare Diagnostics Inc.	11
Trinity Biotech (Primus Corporation dba Trinity Biotech)	10
Bio-Rad Laboratories Inc.	8
Abbott Medical	7
Isolab, Inc.	7
Metrika, Inc.	7
Roche Diagnostics GmbH	6
Diazyme Laboratories, Inc.	5

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 56 companies shown, in name order