CHH · Class I · 21 CFR 862.1175

FDA Product Code CHH: Enzymatic Esterase--oxidase, Cholesterol

Leading manufacturers include Em Diagnostic Systems, Inc., Boehringer Mannheim Corp. and Beckman Instruments, Inc..

230
Total
230
Cleared
87d
Avg days
1976
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg 264d recently vs 86d historically

FDA 510(k) Cleared Enzymatic Esterase--oxidase, Cholesterol Devices (Product Code CHH)

230 devices
1–24 of 230
Cleared Dec 30, 2025
Lipids
K251091
Truvian Health
Chemistry · 264d
Cleared Aug 09, 2024
CHOLESTEROL
K232404
Medicon Hellas S.A
Chemistry · 365d
Cleared Jun 30, 2022
Cholesterol2
K203597
Abbott Ireland Diagnostics Division
Chemistry · 568d
Cleared Mar 27, 2019
VITROS XT Chemistry Products TRIG-CHOL Slides
K190490
Ortho-Clinical Diagnostics, Inc.
Chemistry · 27d
Cleared Oct 18, 2018
Extended Lipid Panel Assay
K181373
Laboratory Corporation of America Holdings
Chemistry · 147d
Cleared Mar 28, 2018
Mission Lipid Panel Monitoring System
K180504
ACON Laboratories, Inc.
Chemistry · 30d
Cleared Jul 11, 2017
Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System
K163406
ACON Laboratories, Inc.
Chemistry · 218d
Cleared Sep 29, 2015
Cholesterol
K150654
Randox Laboratories, Ltd.
Chemistry · 200d
Cleared Feb 20, 2008
EASYRA CHOLESTEROL REAGENT
K072249
Medica Corp.
Chemistry · 191d
Cleared Aug 23, 2005
ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL, ACCUCHEK INSTANT PLUS GLUCOCOSE
K051376
Roche Diagnostics
Chemistry · 89d
Cleared Jul 09, 2003
COBAS INTEGRA CHOLESTEROL GEN. 2
K031824
Roche Diagnostics Corp.
Chemistry · 26d
Cleared Sep 13, 1999
SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP
K992803
Sigma Diagnostics, Inc.
Chemistry · 25d
Cleared Jun 29, 1998
CHOL
K981652
Abbott Laboratories
Chemistry · 49d
Cleared Jun 25, 1998
CHOL
K981476
Abbott Laboratories
Chemistry · 62d
Cleared Apr 21, 1998
INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401)
K980667
Sigma Diagnostics, Inc.
Chemistry · 60d
Cleared Dec 18, 1997
COBAS INTEGRA HDL-CHOLESTEROL DIRECT
K973284
Roche Diagnostic Systems, Inc.
Chemistry · 107d
Cleared Sep 24, 1997
CHOLESTEROL RAPID LIQUID REAGENT
K972853
Reagents Applications, Inc.
Chemistry · 89d
Cleared Jun 11, 1997
SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT
K971505
Beckman Instruments, Inc.
Chemistry · 47d
Cleared Sep 27, 1996
CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)
K962890
Trace Scientific , Ltd.
Chemistry · 65d
Cleared Mar 06, 1996
ACCU-CHEK INSTANT PLUS CHOLOESTEROL TEST
K944458
Boehringer Mannheim Corp.
Chemistry · 541d
Cleared Aug 23, 1995
DMA TOTAL CHOLESTEROL PROCEDURE
K946161
Data Medical Associates, Inc.
Chemistry · 247d
Cleared Jul 20, 1995
BOEHRINGER MANNHEIM CHOLESTEROL ASSAY
K952127
Boehringer Mannheim Corp.
Chemistry · 73d
Cleared Oct 31, 1994
ROCHE REAGENT
K941573
Roche Diagnostic Systems, Inc.
Chemistry · 214d
Cleared Jan 10, 1994
CHOLESTEROL ENZYMATIC ENDPOINT
K923504
Randox Laboratories, Ltd.
Chemistry · 544d

About Product Code CHH - Regulatory Context

510(k) Submission Activity

230 total 510(k) submissions under product code CHH since 1976, with 230 receiving FDA clearance (average review time: 87 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - CHH Product Code

Recent submissions under CHH have taken an average of 264 days to reach a decision - up from 86 days historically. Manufacturers should account for longer review timelines in current project planning.

CHH devices are reviewed by the Chemistry panel. Browse all Chemistry devices →