FDA Product Code CHH: Enzymatic Esterase--oxidase, Cholesterol
Leading manufacturers include Cholestech Corp., Em Diagnostic Systems, Inc. and Boehringer Mannheim Corp..
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
Cleared
Dec 30, 2025
Lipids
Truvian Health
Chemistry
264d
Cleared
Aug 09, 2024
CHOLESTEROL
Medicon Hellas S.A
Chemistry
365d
Cleared
Jun 30, 2022
Cholesterol2
Abbott Ireland Diagnostics Division
Chemistry
568d
Cleared
Mar 27, 2019
VITROS XT Chemistry Products TRIG-CHOL Slides
Ortho-Clinical Diagnostics, Inc.
Chemistry
27d
Cleared
Oct 18, 2018
Extended Lipid Panel Assay
Laboratory Corporation of America Holdings
Chemistry
147d
Cleared
Mar 28, 2018
Mission Lipid Panel Monitoring System
ACON Laboratories, Inc.
Chemistry
30d
Cleared
Jul 11, 2017
Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System
ACON Laboratories, Inc.
Chemistry
218d
Cleared
Dec 22, 2016
CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System
Polymer Technology Systems, Inc.
Chemistry
562d
Cleared
Sep 29, 2015
Cholesterol
Randox Laboratories, Ltd.
Chemistry
200d
Cleared
Mar 21, 2014
AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL
Axis-Shield Poc AS
Chemistry
246d
Cleared
Feb 15, 2013
PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM
Abaxis, Inc.
Chemistry
18d
Cleared
Oct 05, 2012
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT
Alfa Wassermann Diagnostic Technologies, Inc.
Chemistry
28d
Cleared
Jul 27, 2012
EON CHOLESTEROL REAGENT
Vital Diagnostics Pty., Ltd.
Chemistry
186d
Cleared
Jul 03, 2012
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT
Alfa Wassermann Diagnostic Technologies, Inc.
Chemistry
242d
Cleared
Mar 29, 2012
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT
Alfa Wassermann Diagnostic Technologies, Inc.
Chemistry
210d
Cleared
Dec 14, 2011
HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE
Hitachi Chemical Diagnostics, Inc.
Chemistry
175d
Cleared
Nov 17, 2008
CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA
Jas Diagnostics, Inc.
Chemistry
257d
Cleared
Feb 20, 2008
EASYRA CHOLESTEROL REAGENT
Medica Corp.
Chemistry
191d
Cleared
Oct 15, 2007
PTS PANELS CHOL+HDL PANEL TEST STRIPS
Polymer Technology Systems, Inc.
Chemistry
126d
Cleared
Aug 23, 2005
ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL, ACCUCHEK INSTANT PLUS GLUCOCOSE
Roche Diagnostics
Chemistry
89d
Cleared
Nov 24, 2004
SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL
Arkray, Inc.
Chemistry
76d
Cleared
Jul 09, 2003
COBAS INTEGRA CHOLESTEROL GEN. 2
Roche Diagnostics Corp.
Chemistry
26d
Cleared
Jan 24, 2003
PICCOLO TOTAL CHOLESTEROL TEST SYSTEM
Abaxis, Inc.
Chemistry
86d
Cleared
Nov 15, 2002
PTS PANELS LIPID PANEL TEST STRIPS
Polymer Technology Systems, Inc.
Chemistry
23d
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 →