Product Code: CHH FDA class 1 21 CFR 862.1175

Enzymatic Esterase--Oxidase, Cholesterol

Clinical Chemistry

The Enzymatic Esterase-Oxidase, Cholesterol test system (product code CHH) is an in-vitro diagnostic device used in clinical chemistry to measure total cholesterol in serum or plasma using an enzymatic esterase-oxidase coupled reaction, one of the most commonly used methods for lipid panel testing. It is classified as FDA Class 1, the lowest risk tier, subject to general controls only and not requiring premarket notification. It falls under regulation 21 CFR 862.1175 in the Clinical Chemistry medical specialty.

View on FDA

510(k)s

230

FEI Numbers

Registration Numbers

Unique Applicants

129

Years Active

Research product code CHH in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: CHH
Device Class: FDA class 1
Regulation Number: 862.1175
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 230 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251091	Lipids	Dec 30, 2025	Substantially Equivalent	Truvian Health
K232404	CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES	Aug 09, 2024	Substantially Equivalent	Medicon Hellas S.A
K203597	Cholesterol2	Jun 30, 2022	Substantially Equivalent	Abbott Ireland Diagnostics Division
K190490	VITROS XT Chemistry Products TRIG-CHOL Slides	Mar 27, 2019	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K181373	Extended Lipid Panel Assay	Oct 18, 2018	Substantially Equivalent	Laboratory Corporation of America Holdings
K180504	Mission Lipid Panel Monitoring System	Mar 28, 2018	Substantially Equivalent	ACON Laboratories, Inc.
K163406	Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System	Jul 11, 2017	Substantially Equivalent	ACON Laboratories, Inc.
K151545	CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System	Dec 22, 2016	Substantially Equivalent	Polymer Technology Systems, Inc.
K150654	Cholesterol	Sep 29, 2015	Substantially Equivalent	Randox Laboratories, Ltd.
K132031	AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL	Mar 21, 2014	Substantially Equivalent	Axis-Shield Poc AS
K130200	PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM	Feb 15, 2013	Substantially Equivalent	Abaxis, Inc.
K122757	ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT	Oct 05, 2012	Substantially Equivalent	Alfa Wassermann Diagnostic Technologies, Inc.
K120202	EON CHOLESTEROL REAGENT	Jul 27, 2012	Substantially Equivalent	Vital Diagnostics Pty., Ltd.
K113262	ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT	Jul 03, 2012	Substantially Equivalent	Alfa Wassermann Diagnostic Technologies, Inc.
K112538	ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT	Mar 29, 2012	Substantially Equivalent	Alfa Wassermann Diagnostic Technologies, Inc.
K111753	HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE	Dec 14, 2011	Substantially Equivalent	Hitachi Chemical Diagnostics, Inc.
K091413	S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG)	Oct 26, 2009	Substantially Equivalent	Alfa Wassermann, Inc.
K080623	CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA	Nov 17, 2008	Substantially Equivalent	Jas Diagnostics, Inc.
K072249	EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT	Feb 20, 2008	Substantially Equivalent	Medica Corp.
K071593	PTS PANELS CHOL+HDL PANEL TEST STRIPS	Oct 15, 2007	Substantially Equivalent	Polymer Technology Systems, Inc.
K062026	VAP-NT CHOLESTEROL TEST	Mar 06, 2007	Substantially Equivalent	Atherotech, Inc.
K051376	ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL, ACCUCHEK INSTANT PLUS GLUCOCOSE	Aug 23, 2005	Substantially Equivalent	Roche Diagnostics
K042443	SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL	Nov 24, 2004	Substantially Equivalent	Arkray, Inc.
K031824	COBAS INTEGRA CHOLESTEROL GEN. 2	Jul 09, 2003	Substantially Equivalent	Roche Diagnostics Corp.
K023642	PICCOLO TOTAL CHOLESTEROL TEST SYSTEM	Jan 24, 2003	Substantially Equivalent	Abaxis, Inc.
K023558	PTS PANELS LIPID PANEL TEST STRIPS	Nov 15, 2002	Substantially Equivalent	Polymer Technology Systems, Inc.
K022898	PTS PANELS LIPID PANEL TEST STRIPS	Sep 24, 2002	Substantially Equivalent	Polymer Technology Systems, Inc.
K013173	BIOSCANNER PLUS; LIPID PANEL TEST STRIPS	Oct 22, 2001	Substantially Equivalent	Polymer Technology Systems, Inc.
K011970	BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM	Sep 26, 2001	Substantially Equivalent	Biosafe Laboratories, Inc.
K001032	RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY	Jul 24, 2000	Substantially Equivalent	Otsuka Pharmaceutical Co., Ltd.
K000610	RESOLUTION CHOLESTEROL MONITOR	Jul 21, 2000	Substantially Equivalent	Lifestream Technologies, Inc.
K000900	ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS	May 02, 2000	Substantially Equivalent	Elan Holdings, Inc.
K993096	PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL MONITOR	Dec 20, 1999	Substantially Equivalent	Lifestream Technologies, Inc.
K992803	SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP	Sep 13, 1999	Substantially Equivalent	Sigma Diagnostics, Inc.
K992132	CHOLESITE TEST SYSTEM	Aug 20, 1999	Substantially Equivalent	Gds Technology, LLC
K991083	RLP CHOLESTEROL IMMUNOSEPARATION ASSAY	Aug 20, 1999	Substantially Equivalent	Otsuka Pharmaceutical Co., Ltd.
K990688	MTM BIOSCANNER C TEST STRIPS	Jun 24, 1999	Substantially Equivalent	Polymer Technology Systems, Inc.
K981345	CHOLESTRON PRO II CHOLESTEROL TEST	Oct 01, 1998	Substantially Equivalent	Lifestream Diagnostics, Inc.
K982469	HICHEM CHOLESTEROL REAGENT KIT	Aug 19, 1998	Substantially Equivalent	Elan Pharma, Inc.
K981181	ENA-C-T TOTAL CHOLESTEROL TEST MODEL F 20000, (PHYSICIAN DIRECTED USE)	Aug 03, 1998	Substantially Equivalent	Actimed Laboratories, Inc.
K982118	CARESIDE ANALYZER	Jul 24, 1998	Substantially Equivalent	Exigent Diagnostics, Inc.
K981493	MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220	Jul 22, 1998	Substantially Equivalent	Polymer Technology Systems, Inc.
K981652	CHOL	Jun 29, 1998	Substantially Equivalent	Abbott Laboratories
K981476	CHOL	Jun 25, 1998	Substantially Equivalent	Abbott Laboratories
K980667	INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401)	Apr 21, 1998	Substantially Equivalent	Sigma Diagnostics, Inc.
K973284	COBAS INTEGRA HDL-CHOLESTEROL DIRECT	Dec 18, 1997	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K972853	CHOLESTEROL RAPID LIQUID REAGENT	Sep 24, 1997	Substantially Equivalent	Reagents Applications, Inc.
K971072	CHOLESTEROL REAGENT	Jun 20, 1997	Substantially Equivalent	Derma Media Lab., Inc.
K971505	SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT	Jun 11, 1997	Substantially Equivalent	Beckman Instruments, Inc.
K964660	PARAMAX CHOLESTEROL REAGENT	Jun 04, 1997	Substantially Equivalent	Dade Intl., Inc.
K971345	CHOL OR CHOLESTEROL	May 29, 1997	Substantially Equivalent	Carolina Liquid Chemistries Corp.
K962890	CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)	Sep 27, 1996	Substantially Equivalent	Trace Scientific , Ltd.
K960377	ENA-C-T TOTAL CHOLESTEROL TEST	May 02, 1996	Substantially Equivalent	Actimed Laboratories, Inc.
K944458	ACCU-CHEK INSTANT PLUS CHOLOESTEROL TEST	Mar 06, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K946161	DMA TOTAL CHOLESTEROL PROCEDURE	Aug 23, 1995	Substantially Equivalent	Data Medical Associates, Inc.
K952127	BOEHRINGER MANNHEIM CHOLESTEROL ASSAY	Jul 20, 1995	Substantially Equivalent	Boehringer Mannheim Corp.
K950164	PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR	Apr 13, 1995	Substantially Equivalent	Abaxis, Inc.
K943599	CHEM TRAK ACCUMETER	Mar 21, 1995	Substantially Equivalent	Chemtrak, Inc.
K946067	TOTAL CHOLESTEROL, HDL CHOLESTEROL, TRIGLYCERIDES AND GLUCOSE PANEL	Feb 22, 1995	Substantially Equivalent	Cholestech Corp.
K946066	TOTAL CHOLESTEROL, HDL CHOLESTEROL AND GLUCOSE PANEL	Feb 22, 1995	Substantially Equivalent	Cholestech Corp.
K946065	TOTAL CHOLESTEROLM HDL CHOLESTEROL AND TRIGLYCERIDES PANEL	Feb 22, 1995	Substantially Equivalent	Cholestech Corp.
K946064	TOTAL CHOLESTEROL CASSETTE	Feb 22, 1995	Substantially Equivalent	Cholestech Corp.
K946063	TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL	Feb 22, 1995	Substantially Equivalent	Cholestech Corp.
K943027	CHOLESTEROL QVET	Jan 27, 1995	Substantially Equivalent	Prisma Systems
K941573	ROCHE REAGENT	Oct 31, 1994	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K923504	CHOLESTEROL ENZYMATIC ENDPOINT	Jan 10, 1994	Substantially Equivalent	Randox Laboratories, Ltd.
K935136	CHOLESTEROL (CHOL) TEST ITEM NO. 65410	Dec 16, 1993	Substantially Equivalent	Em Diagnostic Systems, Inc.
K934046	BECKMAN CHOLESTEROL REAGENT	Oct 28, 1993	Substantially Equivalent	Beckman-Diagnostic Systems Group
K914432	ACCUMETER(R) CHOLESTEROL SELF-TEST	Mar 02, 1993	Substantially Equivalent	Chemtrak, Inc.
K925603	OLYMPUS CHOLESTEROL REAGENT	Feb 08, 1993	Substantially Equivalent	Olympus Corp.
K924508	CHOLESTEROL TEST ITEM# 42374/93, 42322/R1	Jan 28, 1993	Substantially Equivalent	Em Diagnostic Systems, Inc.
K922231	OLYMPUS CHOLESTEROL REAGENT	Nov 18, 1992	Substantially Equivalent	Olympus Corp.
K923733	CHOLESTEROL TEST	Oct 26, 1992	Substantially Equivalent	Em Diagnostic Systems, Inc.
K923128	KING DIAGNOSTICS CHOLESTEROL REAGENT	Sep 09, 1992	Substantially Equivalent	King Diagnostics, Inc.
K922612	CHOLESTECH LIPID MONITORING SYSTEM, TOTAL CHOLESTE	Jun 24, 1992	Substantially Equivalent	Cholestech Corp.
K914160	CHOLESTEROL REGEANT SET	Jan 30, 1992	Substantially Equivalent	Tech Intl. Co.
K913565	ABBOTT QUICKSTART CHOLESTEROL TEST	Dec 18, 1991	Substantially Equivalent	Em Diagnostic Systems, Inc.
K914469	CHOLESTECH LIPID MONIT SYST, TOTAL CHOL/TRIG PANEL	Oct 30, 1991	Substantially Equivalent	Cholestech Corp.
K912499	KING DIAGNOSTICS CHOLESTEROL REAGENT STRIP TEST	Sep 27, 1991	Substantially Equivalent	King Diagnostics, Inc.
K912212	PROACT CHOLESTEROL SYSTEMS	Aug 28, 1991	Substantially Equivalent	Boehringer Mannheim Corp.
K911692	ENZYMATICS, INC., TOTAL CHOLESTEROL TEST	Aug 16, 1991	Substantially Equivalent	Enzymatics C/O Burditt,Bowles,Radzius & Ruberry
K912136	CHOLESTECH LIPID MONITORING SYS.	Jul 30, 1991	Substantially Equivalent	Cholestech Corp.
K911578	CHOLESTECH L.D.X. LIPID ANALYZER, MODIFICATION	May 15, 1991	Substantially Equivalent	Cholestech Corp.
K905405	CHEMTRAK ACCUMETER CHOLESTEROL TEST	Mar 19, 1991	Substantially Equivalent	Chemtrak, Inc.
K904031	CHEMA CHOL CHOLESTEROL SYSTEM	Mar 11, 1991	Substantially Equivalent	Texas Intl. Laboratories, Inc.
K905648	CRP LIPID REAGENT TEST PACK	Mar 06, 1991	Substantially Equivalent	Cirrus Diagnostics, Inc.
K910240	CHOLESTAT (TM) WHOLE BLOOD CHOLESTEROL TEST	Feb 26, 1991	Substantially Equivalent	Crystal Diagnostics, Inc.
K905145	ECLIPSE ICA CHOLESTEROL	Feb 26, 1991	Substantially Equivalent	Biotope, Inc.
K903126	CHOLESTAT(TM) WHOLE BLOOD CHOLESTEROL TEST	Dec 26, 1990	Substantially Equivalent	Crystal Diagnostics, Inc.
K903015	SYNERMED CHOLESTEROL REAGENT KIT	Oct 01, 1990	Substantially Equivalent	Synermed, Inc.
K902678	LIQUID STABLE CHOLESTEROL REAGENT KIT	Sep 25, 1990	Substantially Equivalent	Trace Scientific , Ltd.
K902098	CHOLESTEROL (RATE) REAGENT	Aug 09, 1990	Substantially Equivalent	Sigma Chemical Co.
K901900	L.D.X LIPID MONITORING SYSTEM	Jul 24, 1990	Substantially Equivalent	Cholestech Corp.
K896467	SATELLITE C BLOOD CHOLESTEROL MONITORING SYSTEM	Jun 12, 1990	Substantially Equivalent	Medisense, Inc.
K900850	EMDS CHOLESTEROL (CHO), ITEM NUMBERS 65410	Mar 29, 1990	Substantially Equivalent	Em Diagnostic Systems, Inc.
K897162	COULTER CHOLESTEROL REAGENT	Mar 29, 1990	Substantially Equivalent	Coulter Electronics, Inc.
K897036	IMMUNOTECH CHOLESTEROL TEST	Mar 06, 1990	Substantially Equivalent	Immunotech Corp.
K896239	COBAS READY CHOLESTEROL REAGENT	Feb 16, 1990	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K895951	CHOLESTEROL TEST KIT	Feb 16, 1990	Substantially Equivalent	Elite Technology, Inc.
K896073	CHOLESTEROL, UNIVERSAL ET	Dec 12, 1989	Substantially Equivalent	Enzyme Technology, Inc.
K895158	VISION WHOLE BLOOD HDL CHOLESTEROL	Oct 02, 1989	Substantially Equivalent	Abbott Laboratories
K893916	EMDS CHOLESTEROL (CHO), ITEM NUMBER 65410	Aug 28, 1989	Substantially Equivalent	Em Diagnostic Systems, Inc.
K893479	CHOLESTEROL REAGENT SET	Jun 19, 1989	Substantially Equivalent	American Monitor Corp.
K891922	AMRESCO CHOLESTEROL REAGENTS, PROD. # 7325	Jun 16, 1989	Substantially Equivalent	American Research Products Co.
K892238	CLA 200 CHEMPRO(R) LIPID ANALYZER	Jun 07, 1989	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K890334	TOTAL CHOLESTEROL REAGENT	May 03, 1989	Substantially Equivalent	Alpkem Corp.
K890267	QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA	Apr 26, 1989	Substantially Equivalent	Photec Diagnostics, Inc.
K890027	QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD	Apr 26, 1989	Substantially Equivalent	Photec Diagnostics, Inc.
K890990	EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE	Apr 10, 1989	Substantially Equivalent	Hichem Diagnostics
K884757	CLINISTAT CHOLESTEROL REAGENT TEST	Mar 10, 1989	Substantially Equivalent	Heraeus Kulzer, Inc.
K885023	CHOLESTEROL TEST ITEM NUMBER: SR1011	Feb 17, 1989	Substantially Equivalent	Em Diagnostic Systems, Inc.
K883543	HDL-CHOLESTEROL PRECIPITATING REAGENT	Dec 16, 1988	Substantially Equivalent	Medical Analysis Systems, Inc.
K880723	DIMENSION WHOLE BLOOD CHOLESTEROL	Nov 08, 1988	Substantially Equivalent	Technimed, Inc.
K883844	HI CHEM KINETIC CHOLESTEROL REAGENT #88218	Oct 31, 1988	Substantially Equivalent	Hichem Diagnostics
K864159	SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD	Jun 10, 1988	Substantially Equivalent	Chem-Elec, Inc.
K880237	CHOLESTEROL	Apr 28, 1988	Substantially Equivalent	Tech-Neal Scientific, Inc.
K880311	WAKO(TM) AUTOKIT CHOLESTEROL	Mar 01, 1988	Substantially Equivalent	Wako Chemicals USA, Inc.
K875131	(SKD) CHOLESTEROL TEST KIT	Mar 01, 1988	Substantially Equivalent	Smithkline Diagnostics, Inc.
K872930	BIOTROL CHOLESTEROL ENZYMATIQUE COLOR	Aug 21, 1987	Substantially Equivalent	Biotrol, USA, Inc.
K872575	HDL CHOLESTEROL REAGENT	Jul 16, 1987	Substantially Equivalent	Sigma Chemical Co.
K872295	CHOLESTEROL REAGENT	Jul 16, 1987	Substantially Equivalent	Sigma Diagnostics, Inc.
K871676	ENZYMATIC CHOLESTEROL REAGENT SET	May 18, 1987	Substantially Equivalent	Michclone Associates, Inc.
K870928	CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS	Apr 22, 1987	Substantially Equivalent	Electro-Nucleonics Laboratories, Inc.
K871260	CHOLESTEROL DETERMINATION	Apr 13, 1987	Substantially Equivalent	Biochemical Trade, Inc.
K870828	INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT	Mar 13, 1987	Substantially Equivalent	Intersect Systems, Inc.
K870407	EASY-TEST CHOLESTEROL(CHOL) NUMBER 16607	Mar 04, 1987	Substantially Equivalent	Em Diagnostic Systems, Inc.
K863103	PEG 6,000	Jan 13, 1987	Substantially Equivalent	J. D. Assoc.
K864081	U.S. DIAGNOSTICS SERUM CHOLESTEROL TEST	Dec 04, 1986	Substantially Equivalent	U. S. Diagnostics, Inc.
K863927	CHOLESTEROL	Nov 24, 1986	Substantially Equivalent	Tech-Co, Inc.
K863252	CHOLESTEROL PROCEDURE	Sep 29, 1986	Substantially Equivalent	Data Medical Associates, Inc.
K863062	CHOLESTEROL-E (TOTAL)	Sep 25, 1986	Substantially Equivalent	J. D. Assoc.
K863064	CHOLESTEROL-E (FREE)	Sep 11, 1986	Substantially Equivalent	J. D. Assoc.
K863063	CHOLESTEROL-E FAST (TOTAL)	Sep 09, 1986	Substantially Equivalent	J. D. Assoc.
K862707	EMDS(TM) CHOLESTEROL TESTPACK, # 67685/95	Aug 19, 1986	Substantially Equivalent	Em Diagnostic Systems, Inc.
K862507	FAST CHOLESTEROL (TOTAL CHOLESTEROL TEST)	Jul 16, 1986	Substantially Equivalent	Sclavo, Inc.
K861659	CHOLESTEROL PROCEDURE	Jun 13, 1986	Substantially Equivalent	Data Medical Associates, Inc.
K861700	DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM	Jun 11, 1986	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K860717	ENZYMATIC CHOLESTEROL REAGENT (SINGLE VIAL)	Apr 11, 1986	Substantially Equivalent	Trace Scientific , Ltd.
K855028	TOTAL CHOLESTEROL REAGENT SET	Jan 28, 1986	Substantially Equivalent	Sterling Diagnostics, Inc.
K854426	KODAK EKTACHEM HDL CHOLESTEROL KIT	Jan 17, 1986	Substantially Equivalent	Eastman Kodak Company
K855187	ENZYMATIC CHOLESTROL REAGENT SET	Jan 14, 1986	Substantially Equivalent	Technostics Intl.
K854179	IN-VITRO TEST FOR THE DETERMINATION OF CHOLESTEROL	Nov 25, 1985	Substantially Equivalent	Clinical Data, Inc.
K853854	ASTRA SYSTEMS CHOLESTEROL REAGENT	Oct 28, 1985	Substantially Equivalent	Beckman Instruments, Inc.
K853871	QCA ENZYMATIC CHOLESTEROL	Oct 04, 1985	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K852863	CHOLESTEROL METHOD	Jul 23, 1985	Substantially Equivalent	Catachem, Inc.
K850390	CHOLESTEROL TEST SYSTEM	Jul 09, 1985	Substantially Equivalent	Hans J. Brouwers & Assoc.
K852009	T-CHO REAGENT	May 30, 1985	Substantially Equivalent	Alpkem Corp.
K844655	PERIDOCHROM CHOLESTEROL HIGH PERFORMANCE	Jan 07, 1985	Substantially Equivalent	Boehringer Mannheim Corp.
K844242	CHOLESTEROL REAGENT FOR DEMAND ANALYZER	Jan 03, 1985	Substantially Equivalent	Advanced Biomedical Methods, Inc.
K843510	PDA CHOLESTEROL	Sep 28, 1984	Substantially Equivalent	Abbott Laboratories
K843222	ENZYMATIC CHOLESTEROL KIT	Sep 28, 1984	Substantially Equivalent	Livonia Diagnostics, Inc.
K843327	SYSTEMATE CHOLESTEROL 67222	Sep 14, 1984	Substantially Equivalent	Em Diagnostic Systems, Inc.
K842160	CHOLESTEROL ASSSAY KIT	Aug 17, 1984	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K842320	TDX REA CHOLESTEROL	Aug 15, 1984	Substantially Equivalent	Abbott Laboratories
K842441	AXIOM STABLE II CHOLESTEROL TEST	Jul 25, 1984	Substantially Equivalent	Axiom, Inc.
K841182	MULTIPLE CHEM. MODULE FOR ANALYSIS	May 09, 1984	Substantially Equivalent	Beckman Instruments, Inc.
K841053	CHOLESTEROL REAGENT SET ENZYMATIC	May 01, 1984	Substantially Equivalent	Medical Specialties, Inc.
K840776	PARAMAX CHOLESTEROL REAGENT	Apr 04, 1984	Substantially Equivalent	American Dade
K840368	DURAZYME CHOLESTEROL	Mar 30, 1984	Substantially Equivalent	American Monitor Corp.
K840189	TOTAL CHOLESTEROL REAGENT SET	Mar 23, 1984	Substantially Equivalent	Preventive Diagnostics Corp.
K832780	FLOW-PAC SHOLESTEROL REAGENT SET	Oct 14, 1983	Substantially Equivalent	American Research Products Co.
K832158	CHOLESTEROL HIGH PERFORMANCE-K	Aug 16, 1983	Substantially Equivalent	Boehringer Mannheim Corp.
K831863	CHOLESTEROL-ENZYMATIC REAGENT SET	Jul 22, 1983	Substantially Equivalent	Stanbio Laboratory
K831700	MULTICHEM ENZYMATIC CHOLESTEROL SYS	Jul 19, 1983	Substantially Equivalent	Simmler, Inc.
K831687	WAKO CHOLESTEROL CII	Jul 18, 1983	Substantially Equivalent	Wako Chemicals USA, Inc.
K830761	WAKO FREE CHOLESTEROL C TEST	Apr 18, 1983	Substantially Equivalent	Wako Chemicals USA, Inc.
K830239	ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDA	Apr 05, 1983	Substantially Equivalent	Emd Chemicals, Inc.
K830309	ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDASE	Feb 28, 1983	Substantially Equivalent	Emd Chemicals, Inc.
K823784	ENZYMATIC CHOLESTEROL (COLORIMETRIC	Jan 14, 1983	Substantially Equivalent	Analytical & Research Chemicals, Inc.
K823500	CHOLESTEROL REAGENT	Dec 30, 1982	Substantially Equivalent	Ac Biochemical Laboratories, Inc.
K823354	ULTRACHEM ENZYMATIC CHOLESTEROL OXIDASE	Dec 22, 1982	Substantially Equivalent	Emd Chemicals, Inc.
K823302	CHOLESTEROL CHOD-PAP TEST	Dec 09, 1982	Substantially Equivalent	Boehringer Mannheim Corp.
K823187	CHOLESTEROL HIGH SENSIT. REAGENT ENZYM	Nov 22, 1982	Substantially Equivalent	Rai, Inc.
K822417	NEW ENZYMATIC SINGLE REAGENT FREE CHOL.	Oct 21, 1982	Substantially Equivalent	Sclavo, Inc.
K822418	ULTRACHEM ENZYMATIC CHOL. OXIDASE	Sep 14, 1982	Substantially Equivalent	Emd Chemicals, Inc.
K821441	ENZYMATIC CHOLESTERAL OXIDASE #650550	Jun 01, 1982	Substantially Equivalent	Emd Chemicals, Inc.
K821105	CHOLESTEZYME-V EIKEN	May 05, 1982	Substantially Equivalent	Syn-Kit, Inc.
K820951	ENZYMATIC CHOLESTEROL KIT	Apr 26, 1982	Substantially Equivalent	Anco Medical Reagents & Assoc.
K820950	TOTAL CHOLESTEROL REAGENT SET	Apr 26, 1982	Substantially Equivalent	Sterling Biochemical, Inc.
K820473	ENZYMATIC CHOLESTEROL REAGENT SYSTEM	Mar 11, 1982	Substantially Equivalent	American Monitor Corp.
K820263	KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES	Feb 18, 1982	Substantially Equivalent	Eastman Kodak Company
K813039	ULTRACHEM E-CHOL, ITEM #65025	Nov 10, 1981	Substantially Equivalent	Harleco
K812293	CENTRICHEM CHOLESTEROL REAGENT & CALIBRA	Aug 31, 1981	Substantially Equivalent	Baker Diagnostics
K812100	SERALYZER	Aug 12, 1981	Substantially Equivalent	Miles Laboratories, Inc.
K812091	FAST CHOLES-CINET	Aug 12, 1981	Substantially Equivalent	Sclavo, Inc.
K811760	CHOLESTEROL DETERMINATION	Jul 10, 1981	Substantially Equivalent	Biorent Diagnostic, Inc.
K810673	ENZYMATIC CHOLESTEROL	Mar 31, 1981	Substantially Equivalent	Pointe Scientific, Inc.,
K810405	CHOLESTEROL REAGENT	Feb 26, 1981	Substantially Equivalent	Gilford Diagnostics
K803287	CHOLESTEROL REAGENT ENZYMATIC	Jan 16, 1981	Substantially Equivalent	Rai, Inc.
K803254	LIQUID-STAT REAGENT FOR ASSAY OF CHOLES.	Jan 09, 1981	Substantially Equivalent	Beckman Instruments, Inc.
K802743	AMES SERA-PAK CHOLESTEROL REAGENT KIT	Dec 10, 1980	Substantially Equivalent	Miles Laboratories, Inc.
K801285	YSI MODELS 23C & 23CM HDL & TOTAL CHOLES	Jul 28, 1980	Substantially Equivalent	Yellow Springs Instrument Co., Inc.
K801296	COBAS REAGENT FOR CHOLESTEROL	Jun 30, 1980	Substantially Equivalent	Roche Analytical Instruments, Inc.
K800765	CENTRIFICHEM CHOLESTEROL	Apr 24, 1980	Substantially Equivalent	Union Carbide Corp.
K800457	LIQUID-STAT LIQUID REAGENT	Mar 20, 1980	Substantially Equivalent	Beckman Instruments, Inc.
K800199	LINEAR ENZYMATIC CHOLESTEROL SYSTEM	Feb 21, 1980	Substantially Equivalent	Simmler, Inc.
K792509	ACA HIGH DENSITY LIPOPROTEIN CHOLES.	Jan 11, 1980	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K792478	CHEM-STRATE CHOLESTEROL	Dec 27, 1979	Substantially Equivalent	General Diagnostics
K791511	ENZYMATIC REAGENT SET, 4X250 ML.	Sep 04, 1979	Substantially Equivalent	Macomb Chemical Co.
K790947	AUTO ENZYMATIC CHOLESTEROL	Jun 28, 1979	Substantially Equivalent	Macomb Chemical Co.
K790768	WAKO CHOLESTEROL TEST	May 23, 1979	Substantially Equivalent	Wako Intl., Inc.
K790760	REAGENT SYSTEM #350HDL, SIGMA PROCEDURE	May 23, 1979	Substantially Equivalent	Sigma Chemical Co.
K790724	ENZYMATIC DETERMINATION	May 23, 1979	Substantially Equivalent	Sigma Chemical Co.
K790556	CHOLESTEROL REAGENT, AUTOMATED ENZYMATIC	May 07, 1979	Substantially Equivalent	Calbiochem-Behring Corp.
K781740	REAGENT, HDL	Nov 22, 1978	Substantially Equivalent	Fisher Scientific Co., LLC
K781721	REAGENT SET, CHOLESTEROL	Nov 03, 1978	Substantially Equivalent	Medical Analysis Systems, Inc.
K781013	ENZYMATIC REAGENT FOR CHOLESTEROL MEAS	Jul 28, 1978	Substantially Equivalent	Coulter Electronics, Inc.
K780659	HDL CHOLESTEROL	Jun 13, 1978	Substantially Equivalent	Macomb Chemical Co.
K780783	AUTOZYME CHOLESTEROL-OXIDASE REAGENT KIT	Jun 06, 1978	Substantially Equivalent	J.T. Baker Chemical Co.
K780638	ACCESSORY HDL CHOLESTEROL REAGENT SET	May 26, 1978	Substantially Equivalent	The Dow Chemical Co.
K780635	REAGENT SET HDL CHOLESTEROL	May 19, 1978	Substantially Equivalent	Boehringer Mannheim Corp.
K780523	ULTRACHEM ENZYMATIC CHOLESTEROL 65025	May 19, 1978	Substantially Equivalent	Harleco
K780389	HDL REAGENT SET FOR LIPOPROTEINS	Apr 19, 1978	Substantially Equivalent	Worthington Biochemical Corp.
K780331	CHOLESTEROL RAPID SLAT KIT HDL	Apr 06, 1978	Substantially Equivalent	Pierce Chemical Co.
K772311	WISP MODEL 710	Jan 12, 1978	Substantially Equivalent	Waters Assoc., Inc.
K771731	CHOLAR PRODU&T #17010	Oct 25, 1977	Substantially Equivalent	Hi Chem, Inc.
K771820	ENZYMATIC CHOLESTEROL	Oct 19, 1977	Substantially Equivalent	Macomb Chemical Co.
K771586	CHOLOPAP-HDL	Sep 15, 1977	Substantially Equivalent	Advanced Biomedical Methods, Inc.
K771582	HOLESTEROL DELTA TEST ASSAY	Sep 13, 1977	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K771508	MULTISTAT III CHOLESTEROL TEST	Sep 13, 1977	Substantially Equivalent	Instrumentation Laboratory CO
K771067	CHOLESTEROL KIT	Jul 21, 1977	Substantially Equivalent	Environmental Chemical Specialties
K770909	ENZYMATIC CHOLESTEROL REAGENT SET	Jul 14, 1977	Substantially Equivalent	American Monitor Corp.
K770780	REAGENTS	Jul 11, 1977	Substantially Equivalent	Chemetrics Corp.
K770483	CHOLESTEROL REAGENT	Jun 08, 1977	Substantially Equivalent	Smithkline Diagnostics, Inc.
K770998	CHOLESTEROL REAGENT SET	Jun 02, 1977	Substantially Equivalent	The Dow Chemical Co.
K770747	REAGENT SET, CHOLESTEROL, CAT NO. 4024	Jun 01, 1977	Substantially Equivalent	American Monitor Corp.
K770265	CHOLESTEROL TEST	Feb 25, 1977	Substantially Equivalent	Sclavo, Inc.
K761136	GLUCOSE ANALYZER 2 W/ CHOLES. REAG KT	Jan 26, 1977	Substantially Equivalent	Beckman Instruments, Inc.
K761089	GLUCOSE ANALYZER W/ CHOLESTEROL REAG KIT	Jan 25, 1977	Substantially Equivalent	Beckman Instruments, Inc.
K761263	CHOLESTEROL AUTOMATED REAGENT	Dec 29, 1976	Substantially Equivalent	Worthington Biochemical Corp.