CHH · Class I · 21 CFR 862.1175

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

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

230
Total
230
Cleared
87d
Avg days
1976
Since
Growing category - 2 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 315d recently vs 85d 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 Jul 09, 2003
COBAS INTEGRA CHOLESTEROL GEN. 2
K031824
Roche Diagnostics Corp.
Chemistry · 26d
Cleared Jun 29, 1998
CHOL
K981652
Abbott Laboratories
Chemistry · 49d
Cleared Jun 25, 1998
CHOL
K981476
Abbott Laboratories
Chemistry · 62d
Cleared Dec 18, 1997
COBAS INTEGRA HDL-CHOLESTEROL DIRECT
K973284
Roche Diagnostic Systems, Inc.
Chemistry · 107d
Cleared Jun 11, 1997
SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT
K971505
Beckman Instruments, Inc.
Chemistry · 47d
Cleared Mar 06, 1996
ACCU-CHEK INSTANT PLUS CHOLOESTEROL TEST
K944458
Boehringer Mannheim Corp.
Chemistry · 541d
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 Dec 16, 1993
CHOLESTEROL (CHOL) TEST ITEM NO. 65410
K935136
Em Diagnostic Systems, Inc.
Chemistry · 49d
Cleared Jan 28, 1993
CHOLESTEROL TEST ITEM# 42374/93, 42322/R1
K924508
Em Diagnostic Systems, Inc.
Chemistry · 146d
Cleared Oct 26, 1992
CHOLESTEROL TEST
K923733
Em Diagnostic Systems, Inc.
Chemistry · 91d
Cleared Dec 18, 1991
ABBOTT QUICKSTART CHOLESTEROL TEST
K913565
Em Diagnostic Systems, Inc.
Chemistry · 131d
Cleared Aug 28, 1991
PROACT CHOLESTEROL SYSTEMS
K912212
Boehringer Mannheim Corp.
Chemistry · 100d
Cleared Aug 09, 1990
CHOLESTEROL (RATE) REAGENT
K902098
Sigma Chemical Co.
Chemistry · 93d
Cleared Mar 29, 1990
EMDS CHOLESTEROL (CHO), ITEM NUMBERS 65410
K900850
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Feb 16, 1990
COBAS READY CHOLESTEROL REAGENT
K896239
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Oct 02, 1989
VISION WHOLE BLOOD HDL CHOLESTEROL
K895158
Abbott Laboratories
Chemistry · 53d

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 increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - CHH Product Code

Recent submissions under CHH have taken an average of 315 days to reach a decision - up from 85 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 →