LBSClass I

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

21 CFR 862.1475 / Clinical Chemistry

LBS is the FDA product code for Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl, a class I device type, regulated under 21 CFR 862.1475. As of 2026-09-10, FDA records hold 80 510(k) clearances under this code, the most recent dated 2016-10-19, and 9 recalls.

Classification record

Product code: LBS
Device name: Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Regulation: 21 CFR 862.1475
Device class: Class I
Review panel: Clinical Chemistry
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 80
Ingested recalls: 9

Clearances, product code LBS

By decision year

80 clearances under product code LBS with a decision year between 1979 and 2016, 1997 the highest year at 7.

Show the numbers

510(k) clearances under FDA product code LBS by decision year
Year	Clearances
1979	5
1980	3
1981	1
1984	3
1986	2
1987	5
1988	1
1989	4
1990	2
1991	1
1993	1
1994	1
1995	2
1996	1
1997	7
1998	5
1999	3
2001	2
2002	5
2003	2
2004	6
2005	3
2006	1
2007	2
2008	3
2010	2
2011	3
2012	1
2014	1
2016	2

Applicants with the most clearances

Product code LBS

Applicants holding the most 510(k) clearances under product code LBS
Applicant	Clearances
Abbott Medical	4
Siemens Healthcare Diagnostics Inc.	4
Beckman Instruments, Inc.	4
Genzyme Corporation	3
Randox Laboratories, Limited	3
A.P. Total Care, Inc.	2
Cholestech Corp.	2
Em Diagnostic Systems, Inc.	2
Kulzer GmbH	2
Medica Corp.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 36 companies shown, in name order