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
1989-06-19
CHH
1989-06-16
AMRESCO CHOLESTEROL REAGENTS, PROD. # 7325
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CHH
1989-06-07
CLA 200 CHEMPRO(R) LIPID ANALYZER
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CHH
1989-05-03
TOTAL CHOLESTEROL REAGENT
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CHH
1989-04-26
QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA
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CHH
1989-04-26
QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD
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CHH
1989-04-10
EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE
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CHH
1989-03-10
CLINISTAT CHOLESTEROL REAGENT TEST
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CHH
1989-02-17
CHOLESTEROL TEST ITEM NUMBER: SR1011
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CHH
1988-12-16
HDL-CHOLESTEROL PRECIPITATING REAGENT
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CHH
1988-11-08
DIMENSION WHOLE BLOOD CHOLESTEROL
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CHH
1988-10-31
HI CHEM KINETIC CHOLESTEROL REAGENT #88218
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CHH
1988-06-10
SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD
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CHH
1988-04-28
CHOLESTEROL
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CHH
1988-03-01
WAKO(TM) AUTOKIT CHOLESTEROL
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CHH
1988-03-01
(SKD) CHOLESTEROL TEST KIT
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CHH
1987-08-21
BIOTROL CHOLESTEROL ENZYMATIQUE COLOR
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CHH
1987-07-16
HDL CHOLESTEROL REAGENT
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CHH
1987-07-16
CHOLESTEROL REAGENT
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CHH
1987-05-18
ENZYMATIC CHOLESTEROL REAGENT SET
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CHH
1987-04-22
CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS
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CHH
1987-04-13
CHOLESTEROL DETERMINATION
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CHH
1987-03-13
INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT
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CHH
1987-03-04
EASY-TEST CHOLESTEROL(CHOL) NUMBER 16607
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CHH
1987-01-13
PEG 6,000
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CHH
1986-12-04
U.S. DIAGNOSTICS SERUM CHOLESTEROL TEST
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CHH
1986-11-24
CHOLESTEROL
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CHH
1986-09-29
CHOLESTEROL PROCEDURE
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CHH
1986-09-25
CHOLESTEROL-E (TOTAL)
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CHH
1986-09-11
CHOLESTEROL-E (FREE)
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CHH
1986-09-09
CHOLESTEROL-E FAST (TOTAL)
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CHH
1986-08-19
EMDS(TM) CHOLESTEROL TESTPACK, # 67685/95
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CHH
1986-07-16
FAST CHOLESTEROL (TOTAL CHOLESTEROL TEST)
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CHH
1986-06-13
CHOLESTEROL PROCEDURE
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CHH
1986-06-11
DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM
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CHH
1986-04-11
ENZYMATIC CHOLESTEROL REAGENT (SINGLE VIAL)
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CHH
1986-01-28
TOTAL CHOLESTEROL REAGENT SET
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CHH
1986-01-17
KODAK EKTACHEM HDL CHOLESTEROL KIT
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CHH
1986-01-14
ENZYMATIC CHOLESTROL REAGENT SET
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CHH
1985-11-25
IN-VITRO TEST FOR THE DETERMINATION OF CHOLESTEROL
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CHH
1985-10-28
ASTRA SYSTEMS CHOLESTEROL REAGENT
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CHH
1985-10-04
QCA ENZYMATIC CHOLESTEROL
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CHH
1985-07-23
CHOLESTEROL METHOD
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CHH
1985-07-09
CHOLESTEROL TEST SYSTEM
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CHH
1985-05-30
T-CHO REAGENT
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CHH
1985-01-07
PERIDOCHROM CHOLESTEROL HIGH PERFORMANCE
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CHH
1985-01-03
CHOLESTEROL REAGENT FOR DEMAND ANALYZER
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CHH
1984-09-28
PDA CHOLESTEROL
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CHH
1984-09-28
ENZYMATIC CHOLESTEROL KIT
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CHH
1984-09-14
SYSTEMATE CHOLESTEROL 67222
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CHH
1984-08-17
CHOLESTEROL ASSSAY KIT
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CHH
1984-08-15
TDX REA CHOLESTEROL
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CHH
1984-07-25
AXIOM STABLE II CHOLESTEROL TEST
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CHH
1984-05-09
MULTIPLE CHEM. MODULE FOR ANALYSIS
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CHH
1984-05-01
CHOLESTEROL REAGENT SET ENZYMATIC
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CHH
1984-04-04
PARAMAX CHOLESTEROL REAGENT
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CHH
1984-03-30
DURAZYME CHOLESTEROL
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CHH
1984-03-23
TOTAL CHOLESTEROL REAGENT SET
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CHH
1983-10-14
FLOW-PAC SHOLESTEROL REAGENT SET
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CHH
1983-08-16
CHOLESTEROL HIGH PERFORMANCE-K
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CHH
1983-07-22
CHOLESTEROL-ENZYMATIC REAGENT SET
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CHH
1983-07-19
MULTICHEM ENZYMATIC CHOLESTEROL SYS
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CHH
1983-07-18
WAKO CHOLESTEROL CII
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CHH
1983-04-18
WAKO FREE CHOLESTEROL C TEST
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CHH
1983-04-05
ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDA
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CHH
1983-02-28
ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDASE
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CHH
1983-01-14
ENZYMATIC CHOLESTEROL (COLORIMETRIC
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CHH
1982-12-30
CHOLESTEROL REAGENT
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CHH
1982-12-22
ULTRACHEM ENZYMATIC CHOLESTEROL OXIDASE
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CHH
1982-12-09
CHOLESTEROL CHOD-PAP TEST
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CHH
1982-11-22
CHOLESTEROL HIGH SENSIT. REAGENT ENZYM
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CHH
1982-10-21
NEW ENZYMATIC SINGLE REAGENT FREE CHOL.
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CHH
1982-09-14
ULTRACHEM ENZYMATIC CHOL. OXIDASE
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CHH
1982-06-01
ENZYMATIC CHOLESTERAL OXIDASE #650550
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CHH
1982-05-05
CHOLESTEZYME-V EIKEN
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CHH
1982-04-26
ENZYMATIC CHOLESTEROL KIT
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CHH
1982-04-26
TOTAL CHOLESTEROL REAGENT SET
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CHH
1982-03-11
ENZYMATIC CHOLESTEROL REAGENT SYSTEM
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CHH
1982-02-18
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
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CHH
1981-11-10
ULTRACHEM E-CHOL, ITEM #65025
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CHH
1981-08-31
CENTRICHEM CHOLESTEROL REAGENT & CALIBRA
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CHH
1981-08-12
SERALYZER
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CHH
1981-08-12
FAST CHOLES-CINET
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CHH
1981-07-10
CHOLESTEROL DETERMINATION
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CHH
1981-03-31
ENZYMATIC CHOLESTEROL
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CHH
1981-02-26
CHOLESTEROL REAGENT
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CHH
1981-01-16
CHOLESTEROL REAGENT ENZYMATIC
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CHH
1981-01-09
LIQUID-STAT REAGENT FOR ASSAY OF CHOLES.
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CHH
1980-12-10
AMES SERA-PAK CHOLESTEROL REAGENT KIT
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CHH
1980-07-28
YSI MODELS 23C & 23CM HDL & TOTAL CHOLES
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CHH
1980-06-30
COBAS REAGENT FOR CHOLESTEROL
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CHH
1980-04-24
CENTRIFICHEM CHOLESTEROL
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CHH
1980-03-20
LIQUID-STAT LIQUID REAGENT
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CHH
1980-02-21
LINEAR ENZYMATIC CHOLESTEROL SYSTEM
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CHH
1980-01-11
ACA HIGH DENSITY LIPOPROTEIN CHOLES.
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CHH
1979-12-27
CHEM-STRATE CHOLESTEROL
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CHH
1979-09-04
ENZYMATIC REAGENT SET, 4X250 ML.
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CHH
1979-06-28
AUTO ENZYMATIC CHOLESTEROL
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CHH
1979-05-23
WAKO CHOLESTEROL TEST
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CHH
1979-05-23
REAGENT SYSTEM #350HDL, SIGMA PROCEDURE
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