ClearanceBrief
Panels › Clinical Chemistry › Product code CHH · Class 1

Enzymatic Esterase--Oxidase, Cholesterol

Regulation 862.1175

1510(k)s in 12 months (230 all time)
1recalls in 12 months (23 all time)
19recalls that name a 510(k)
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Top companies in CHH

Company510(k)sRecalls
Polymer Technology Systems, Inc.77
Cholestech Corp.100
Em Diagnostic Systems, Inc.100
Beckman Instruments, Inc.70
Boehringer Mannheim Corp.70
Abbott Laboratories50
American Monitor Corp.50
Emd Chemicals, Inc.50
Beckman Coulter Inc.04
J. D. Assoc.40
Decided510(k)Device and applicantCode
Dec 30, 2025K251091Lipids
Truvian Health
CHH
Aug 9, 2024K232404CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES
Medicon Hellas S.A, GR
CHH
Jun 30, 2022K203597Cholesterol2
Abbott Ireland Diagnostics Division, IE
CHH
Mar 27, 2019K190490VITROS XT Chemistry Products TRIG-CHOL Slides
Ortho-Clinical Diagnostics, Inc.
CHH
Oct 18, 2018K181373Extended Lipid Panel Assay
Laboratory Corporation of America Holdings
CHH
Mar 28, 2018K180504Mission Lipid Panel Monitoring System
ACON Laboratories, Inc.
CHH
Jul 11, 2017K163406Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System
ACON Laboratories, Inc.
CHH
Dec 22, 2016K151545CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System
Polymer Technology Systems, Inc.
CHH
Sep 29, 2015K150654Cholesterol
Randox Laboratories, Ltd., GB
CHH
Mar 21, 2014K132031AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL
Axis-Shield Poc AS, NO
CHH
Feb 15, 2013K130200PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM
Abaxis, Inc.
CHH
Oct 5, 2012K122757ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT
Alfa Wassermann Diagnostic Technologies, Inc.
CHH
Jul 27, 2012K120202EON CHOLESTEROL REAGENT
Vital Diagnostics Pty., Ltd., AU
CHH
Jul 3, 2012K113262ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT
Alfa Wassermann Diagnostic Technologies, Inc.
CHH
Mar 29, 2012K112538ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT
Alfa Wassermann Diagnostic Technologies, Inc.
CHH
Dec 14, 2011K111753HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE
Hitachi Chemical Diagnostics, Inc.
CHH
Oct 26, 2009K091413S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG)
Alfa Wassermann, Inc.
CHH
Nov 17, 2008K080623CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA
Jas Diagnostics, Inc.
CHH
Feb 20, 2008K072249EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT
Medica Corp.
CHH
Oct 15, 2007K071593PTS PANELS CHOL+HDL PANEL TEST STRIPS
Polymer Technology Systems, Inc.
CHH
Mar 6, 2007K062026VAP-NT CHOLESTEROL TEST
Atherotech, Inc.
CHH
Aug 23, 2005K051376ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL, ACCUCHEK INSTANT PLUS GLUCOCOSE
Roche Diagnostics
CHH
Nov 24, 2004K042443SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL
Arkray, Inc.
CHH
Jul 9, 2003K031824COBAS INTEGRA CHOLESTEROL GEN. 2
Roche Diagnostics Corp.
CHH
Jan 24, 2003K023642PICCOLO TOTAL CHOLESTEROL TEST SYSTEM
Abaxis, Inc.
CHH
Nov 15, 2002K023558PTS PANELS LIPID PANEL TEST STRIPS
Polymer Technology Systems, Inc.
CHH
Sep 24, 2002K022898PTS PANELS LIPID PANEL TEST STRIPS
Polymer Technology Systems, Inc.
CHH
Oct 22, 2001K013173BIOSCANNER PLUS; LIPID PANEL TEST STRIPS
Polymer Technology Systems, Inc.
CHH
Sep 26, 2001K011970BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM
Biosafe Laboratories, Inc.
CHH
Jul 24, 2000K001032RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY
Otsuka Pharmaceutical Co., Ltd.
CHH
Jul 21, 2000K000610RESOLUTION CHOLESTEROL MONITOR
Lifestream Technologies, Inc.
CHH
May 2, 2000K000900ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS
Elan Holdings, Inc.
CHH
Dec 20, 1999K993096PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL MONITOR
Lifestream Technologies, Inc.
CHH
Sep 13, 1999K992803SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP
Sigma Diagnostics, Inc.
CHH
Aug 20, 1999K992132CHOLESITE TEST SYSTEM
Gds Technology, LLC
CHH
Aug 20, 1999K991083RLP CHOLESTEROL IMMUNOSEPARATION ASSAY
Otsuka Pharmaceutical Co., Ltd.
CHH
Jun 24, 1999K990688MTM BIOSCANNER C TEST STRIPS
Polymer Technology Systems, Inc.
CHH
Oct 1, 1998K981345CHOLESTRON PRO II CHOLESTEROL TEST
Lifestream Diagnostics, Inc.
CHH
Aug 19, 1998K982469HICHEM CHOLESTEROL REAGENT KIT
Elan Pharma, Inc.
CHH
Aug 3, 1998K981181ENA-C-T TOTAL CHOLESTEROL TEST MODEL F 20000, (PHYSICIAN DIRECTED USE)
Actimed Laboratories, Inc.
CHH
Jul 24, 1998K982118CARESIDE ANALYZER
Exigent Diagnostics, Inc.
CHH
Jul 22, 1998K981493MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220
Polymer Technology Systems, Inc.
CHH
Jun 29, 1998K981652CHOL
Abbott Laboratories
CHH
Jun 25, 1998K981476CHOL
Abbott Laboratories
CHH
Apr 21, 1998K980667INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401)
Sigma Diagnostics, Inc.
CHH
Dec 18, 1997K973284COBAS INTEGRA HDL-CHOLESTEROL DIRECT
Roche Diagnostic Systems, Inc.
CHH
Sep 24, 1997K972853CHOLESTEROL RAPID LIQUID REAGENT
Reagents Applications, Inc.
CHH
Jun 20, 1997K971072CHOLESTEROL REAGENT
Derma Media Lab., Inc.
CHH
Jun 11, 1997K971505SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT
Beckman Instruments, Inc.
CHH
Jun 4, 1997K964660PARAMAX CHOLESTEROL REAGENT
Dade Intl., Inc.
CHH

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