Enzymatic Esterase--Oxidase, Cholesterol
FDA product code CHH · 228 cleared devices
Class 1
Clinical Chemistry
- Regulation
- 21 CFR 862.1175
- Review panel
- CH
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1976-12-29 – 2025-12-30
CHH
2025-12-30
CHH
2024-08-09
CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES
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CHH
2022-06-30
Cholesterol2
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CHH
2019-03-27
VITROS XT Chemistry Products TRIG-CHOL Slides
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CHH
2018-10-18
Extended Lipid Panel Assay
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CHH
2018-03-28
Mission Lipid Panel Monitoring System
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CHH
2017-07-11
Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System
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CHH
2016-12-22
CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System
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CHH
2013-02-15
PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM
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CHH
2012-10-05
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT
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CHH
2012-07-27
EON CHOLESTEROL REAGENT
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CHH
2012-07-03
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT
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CHH
2012-03-29
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT
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CHH
2011-12-14
HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE
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CHH
2009-10-26
S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG)
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CHH
2008-11-17
CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA
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CHH
2008-02-20
EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT
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CHH
2007-10-15
PTS PANELS CHOL+HDL PANEL TEST STRIPS
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CHH
2007-03-06
VAP-NT CHOLESTEROL TEST
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CHH
2005-08-23
ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL, ACCUCHEK INSTANT PLUS GLUCOCOSE
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CHH
2004-11-24
SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL
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CHH
2003-07-09
COBAS INTEGRA CHOLESTEROL GEN. 2
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CHH
2003-01-24
PICCOLO TOTAL CHOLESTEROL TEST SYSTEM
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CHH
2002-11-15
PTS PANELS LIPID PANEL TEST STRIPS
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CHH
2002-09-24
PTS PANELS LIPID PANEL TEST STRIPS
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CHH
2001-10-22
BIOSCANNER PLUS; LIPID PANEL TEST STRIPS
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CHH
2001-09-26
BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM
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CHH
2000-07-24
RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY
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CHH
2000-07-21
RESOLUTION CHOLESTEROL MONITOR
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CHH
2000-05-02
ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS
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CHH
1999-12-20
PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL MONITOR
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CHH
1999-09-13
SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP
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CHH
1999-08-20
CHOLESITE TEST SYSTEM
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CHH
1999-08-20
RLP CHOLESTEROL IMMUNOSEPARATION ASSAY
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CHH
1999-06-24
MTM BIOSCANNER C TEST STRIPS
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CHH
1998-10-01
CHOLESTRON PRO II CHOLESTEROL TEST
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CHH
1998-08-19
HICHEM CHOLESTEROL REAGENT KIT
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CHH
1998-08-03
ENA-C-T TOTAL CHOLESTEROL TEST MODEL F 20000, (PHYSICIAN DIRECTED USE)
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CHH
1998-07-24
CARESIDE ANALYZER
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CHH
1998-07-22
MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220
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CHH
1998-06-29
CHOL
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CHH
1998-06-25
CHOL
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CHH
1998-04-21
INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401)
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CHH
1997-12-18
COBAS INTEGRA HDL-CHOLESTEROL DIRECT
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CHH
1997-09-24
CHOLESTEROL RAPID LIQUID REAGENT
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CHH
1997-06-20
CHOLESTEROL REAGENT
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CHH
1997-06-11
SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT
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CHH
1997-06-04
PARAMAX CHOLESTEROL REAGENT
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CHH
1997-05-29
CHOL OR CHOLESTEROL
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CHH
1996-09-27
CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)
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CHH
1996-05-02
ENA-C-T TOTAL CHOLESTEROL TEST
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CHH
1996-03-06
ACCU-CHEK INSTANT PLUS CHOLOESTEROL TEST
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CHH
1995-08-23
DMA TOTAL CHOLESTEROL PROCEDURE
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CHH
1995-07-20
BOEHRINGER MANNHEIM CHOLESTEROL ASSAY
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CHH
1995-04-13
PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR
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CHH
1995-03-21
CHEM TRAK ACCUMETER
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CHH
1995-02-22
TOTAL CHOLESTEROL, HDL CHOLESTEROL, TRIGLYCERIDES AND GLUCOSE PANEL
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CHH
1995-02-22
TOTAL CHOLESTEROL, HDL CHOLESTEROL AND GLUCOSE PANEL
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CHH
1995-02-22
TOTAL CHOLESTEROLM HDL CHOLESTEROL AND TRIGLYCERIDES PANEL
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CHH
1995-02-22
TOTAL CHOLESTEROL CASSETTE
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CHH
1995-02-22
TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL
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CHH
1995-01-27
CHOLESTEROL QVET
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CHH
1994-10-31
ROCHE REAGENT
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CHH
1994-01-10
CHOLESTEROL ENZYMATIC ENDPOINT
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CHH
1993-12-16
CHOLESTEROL (CHOL) TEST ITEM NO. 65410
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CHH
1993-10-28
BECKMAN CHOLESTEROL REAGENT
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CHH
1993-03-02
ACCUMETER(R) CHOLESTEROL SELF-TEST
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CHH
1993-02-08
OLYMPUS CHOLESTEROL REAGENT
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CHH
1993-01-28
CHOLESTEROL TEST ITEM# 42374/93, 42322/R1
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CHH
1992-11-18
OLYMPUS CHOLESTEROL REAGENT
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CHH
1992-10-26
CHOLESTEROL TEST
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CHH
1992-09-09
KING DIAGNOSTICS CHOLESTEROL REAGENT
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CHH
1992-06-24
CHOLESTECH LIPID MONITORING SYSTEM, TOTAL CHOLESTE
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CHH
1992-01-30
CHOLESTEROL REGEANT SET
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CHH
1991-12-18
ABBOTT QUICKSTART CHOLESTEROL TEST
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CHH
1991-10-30
CHOLESTECH LIPID MONIT SYST, TOTAL CHOL/TRIG PANEL
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CHH
1991-09-27
KING DIAGNOSTICS CHOLESTEROL REAGENT STRIP TEST
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CHH
1991-08-28
PROACT CHOLESTEROL SYSTEMS
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CHH
1991-08-16
ENZYMATICS, INC., TOTAL CHOLESTEROL TEST
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CHH
1991-07-30
CHOLESTECH LIPID MONITORING SYS.
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CHH
1991-05-15
CHOLESTECH L.D.X. LIPID ANALYZER, MODIFICATION
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CHH
1991-03-19
CHEMTRAK ACCUMETER CHOLESTEROL TEST
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CHH
1991-03-11
CHEMA CHOL CHOLESTEROL SYSTEM
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CHH
1991-03-06
CRP LIPID REAGENT TEST PACK
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CHH
1991-02-26
CHOLESTAT (TM) WHOLE BLOOD CHOLESTEROL TEST
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CHH
1991-02-26
ECLIPSE ICA CHOLESTEROL
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CHH
1990-12-26
CHOLESTAT(TM) WHOLE BLOOD CHOLESTEROL TEST
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CHH
1990-10-01
SYNERMED CHOLESTEROL REAGENT KIT
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CHH
1990-09-25
LIQUID STABLE CHOLESTEROL REAGENT KIT
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CHH
1990-08-09
CHOLESTEROL (RATE) REAGENT
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CHH
1990-07-24
L.D.X LIPID MONITORING SYSTEM
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CHH
1990-06-12
SATELLITE C BLOOD CHOLESTEROL MONITORING SYSTEM
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CHH
1990-03-29
EMDS CHOLESTEROL (CHO), ITEM NUMBERS 65410
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CHH
1990-03-29
COULTER CHOLESTEROL REAGENT
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CHH
1990-03-06
IMMUNOTECH CHOLESTEROL TEST
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CHH
1990-02-16
COBAS READY CHOLESTEROL REAGENT
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CHH
1990-02-16
CHOLESTEROL TEST KIT
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CHH
1989-12-12
CHOLESTEROL, UNIVERSAL ET
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CHH
1989-10-02
VISION WHOLE BLOOD HDL CHOLESTEROL
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CHH
1989-08-28
EMDS CHOLESTEROL (CHO), ITEM NUMBER 65410
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