CHHClass I

Enzymatic Esterase--Oxidase, Cholesterol

21 CFR 862.1175 / Clinical Chemistry

CHH is the FDA product code for Enzymatic Esterase--Oxidase, Cholesterol, a class I device type, regulated under 21 CFR 862.1175. As of 2026-09-10, FDA records hold 230 510(k) clearances under this code, the most recent dated 2025-12-30, and 23 recalls.

Classification record

Product code: CHH
Device name: Enzymatic Esterase--Oxidase, Cholesterol
Regulation: 21 CFR 862.1175
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: 230
Ingested recalls: 23

Clearances, product code CHH

By decision year

230 clearances under product code CHH with a decision year between 1976 and 2025, 1977 the highest year at 14.

Show the numbers

510(k) clearances under FDA product code CHH by decision year
Year	Clearances
1976	1
1977	14
1978	11
1979	7
1980	7
1981	9
1982	12
1983	9
1984	11
1985	8
1986	14
1987	9
1988	7
1989	12
1990	11
1991	12
1992	5
1993	5
1994	2
1995	10
1996	3
1997	6
1998	8
1999	5
2000	3
2001	2
2002	2
2003	2
2004	1
2005	1
2007	2
2008	2
2009	1
2011	1
2012	4
2013	1
2014	1
2015	1
2016	1
2017	1
2018	2
2019	1
2022	1
2024	1
2025	1

Applicants with the most clearances

Product code CHH

Applicants holding the most 510(k) clearances under product code CHH
Applicant	Clearances
Cholestech Corp.	10
Em Diagnostic Systems, Inc.	10
Beckman Instruments, Inc.	7
Boehringer Mannheim Corp.	7
Polymer Technology Systems	7
Abbott Medical	5
American Monitor Corp.	5
EMD Millipore Corporation	5
J. D. Assoc.	4
Macomb Chemical Co.	4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 71 companies shown, in name order