CHH · Enzymatic Esterase--Oxidase, Cholesterol
Clinical Chemistry · 21 CFR 862.1175 · Class 1
Overview
| Product Code | CHH |
|---|---|
| Device Name | Enzymatic Esterase--Oxidase, Cholesterol |
| Regulation | 21 CFR 862.1175 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Cleared Devices (230)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251091 | Lipids | Truvian Health | Dec 30, 2025 | SESE |
| K232404 | CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES | Medicon Hellas S.A | Aug 9, 2024 | SESE |
| K203597 | Cholesterol2 | Abbott Ireland Diagnostics Division | Jun 30, 2022 | SESE |
| K190490 | VITROS XT Chemistry Products TRIG-CHOL Slides | Ortho-Clinical Diagnostics, Inc. | Mar 27, 2019 | SESE |
| K181373 | Extended Lipid Panel Assay | Laboratory Corporation of America Holdings | Oct 18, 2018 | SESE |
| K180504 | Mission Lipid Panel Monitoring System | ACON Laboratories, Inc. | Mar 28, 2018 | SESE |
| K163406 | Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System | ACON Laboratories, Inc. | Jul 11, 2017 | SESE |
| K151545 | CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System | Polymer Technology Systems, Inc. | Dec 22, 2016 | SESE |
| K150654 | Cholesterol | Randox Laboratories, Ltd. | Sep 29, 2015 | SESE |
| K132031 | AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL | Axis-Shield Poc AS | Mar 21, 2014 | SESE |
| K130200 | PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM | Abaxis, Inc. | Feb 15, 2013 | SESE |
| K122757 | ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT | Alfa Wassermann Diagnostic Technologies, Inc. | Oct 5, 2012 | SESE |
| K120202 | EON CHOLESTEROL REAGENT | Vital Diagnostics Pty., Ltd. | Jul 27, 2012 | SESE |
| K113262 | ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT | Alfa Wassermann Diagnostic Technologies, Inc. | Jul 3, 2012 | SESE |
| K112538 | ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT | Alfa Wassermann Diagnostic Technologies, Inc. | Mar 29, 2012 | SESE |
| K111753 | HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE | Hitachi Chemical Diagnostics, Inc. | Dec 14, 2011 | SESE |
| K091413 | S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG) | Alfa Wassermann, Inc. | Oct 26, 2009 | SESE |
| K080623 | CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA | Jas Diagnostics, Inc. | Nov 17, 2008 | SESE |
| K072249 | EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT | Medica Corp. | Feb 20, 2008 | SESE |
| K071593 | PTS PANELS CHOL+HDL PANEL TEST STRIPS | Polymer Technology Systems, Inc. | Oct 15, 2007 | SESE |
| K062026 | VAP-NT CHOLESTEROL TEST | Atherotech, Inc. | Mar 6, 2007 | SESE |
| K051376 | ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL, ACCUCHEK INSTANT PLUS GLUCOCOSE | Roche Diagnostics | Aug 23, 2005 | SESE |
| K042443 | SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL | Arkray, Inc. | Nov 24, 2004 | SESE |
| K031824 | COBAS INTEGRA CHOLESTEROL GEN. 2 | Roche Diagnostics Corp. | Jul 9, 2003 | SESE |
| K023642 | PICCOLO TOTAL CHOLESTEROL TEST SYSTEM | Abaxis, Inc. | Jan 24, 2003 | SESE |
| K023558 | PTS PANELS LIPID PANEL TEST STRIPS | Polymer Technology Systems, Inc. | Nov 15, 2002 | SESE |
| K022898 | PTS PANELS LIPID PANEL TEST STRIPS | Polymer Technology Systems, Inc. | Sep 24, 2002 | SESE |
| K013173 | BIOSCANNER PLUS; LIPID PANEL TEST STRIPS | Polymer Technology Systems, Inc. | Oct 22, 2001 | SESE |
| K011970 | BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM | Biosafe Laboratories, Inc. | Sep 26, 2001 | SESE |
| K001032 | RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY | Otsuka Pharmaceutical Co., Ltd. | Jul 24, 2000 | SESE |
| K000610 | RESOLUTION CHOLESTEROL MONITOR | Lifestream Technologies, Inc. | Jul 21, 2000 | SESE |
| K000900 | ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS | Elan Holdings, Inc. | May 2, 2000 | SESE |
| K993096 | PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL MONITOR | Lifestream Technologies, Inc. | Dec 20, 1999 | SESE |
| K992803 | SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP | Sigma Diagnostics, Inc. | Sep 13, 1999 | SESE |
| K992132 | CHOLESITE TEST SYSTEM | Gds Technology, LLC | Aug 20, 1999 | SESE |
| K991083 | RLP CHOLESTEROL IMMUNOSEPARATION ASSAY | Otsuka Pharmaceutical Co., Ltd. | Aug 20, 1999 | SESE |
| K990688 | MTM BIOSCANNER C TEST STRIPS | Polymer Technology Systems, Inc. | Jun 24, 1999 | SESE |
| K981345 | CHOLESTRON PRO II CHOLESTEROL TEST | Lifestream Diagnostics, Inc. | Oct 1, 1998 | SESE |
| K982469 | HICHEM CHOLESTEROL REAGENT KIT | Elan Pharma, Inc. | Aug 19, 1998 | SESE |
| K981181 | ENA-C-T TOTAL CHOLESTEROL TEST MODEL F 20000, (PHYSICIAN DIRECTED USE) | Actimed Laboratories, Inc. | Aug 3, 1998 | SESE |
| K982118 | CARESIDE ANALYZER | Exigent Diagnostics, Inc. | Jul 24, 1998 | SESE |
| K981493 | MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220 | Polymer Technology Systems, Inc. | Jul 22, 1998 | SESE |
| K981652 | CHOL | Abbott Laboratories | Jun 29, 1998 | SESE |
| K981476 | CHOL | Abbott Laboratories | Jun 25, 1998 | SESE |
| K980667 | INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401) | Sigma Diagnostics, Inc. | Apr 21, 1998 | SESE |
| K973284 | COBAS INTEGRA HDL-CHOLESTEROL DIRECT | Roche Diagnostic Systems, Inc. | Dec 18, 1997 | SESE |
| K972853 | CHOLESTEROL RAPID LIQUID REAGENT | Reagents Applications, Inc. | Sep 24, 1997 | SESE |
| K971072 | CHOLESTEROL REAGENT | Derma Media Lab., Inc. | Jun 20, 1997 | SESE |
| K971505 | SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT | Beckman Instruments, Inc. | Jun 11, 1997 | SESE |
| K964660 | PARAMAX CHOLESTEROL REAGENT | Dade Intl., Inc. | Jun 4, 1997 | SESE |
| K971345 | CHOL OR CHOLESTEROL | Carolina Liquid Chemistries Corp. | May 29, 1997 | SESE |
| K962890 | CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST) | Trace Scientific , Ltd. | Sep 27, 1996 | SESE |
| K960377 | ENA-C-T TOTAL CHOLESTEROL TEST | Actimed Laboratories, Inc. | May 2, 1996 | SESE |
| K944458 | ACCU-CHEK INSTANT PLUS CHOLOESTEROL TEST | Boehringer Mannheim Corp. | Mar 6, 1996 | SESE |
| K946161 | DMA TOTAL CHOLESTEROL PROCEDURE | Data Medical Associates, Inc. | Aug 23, 1995 | SESE |
| K952127 | BOEHRINGER MANNHEIM CHOLESTEROL ASSAY | Boehringer Mannheim Corp. | Jul 20, 1995 | SESE |
| K950164 | PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR | Abaxis, Inc. | Apr 13, 1995 | SESE |
| K943599 | CHEM TRAK ACCUMETER | Chemtrak, Inc. | Mar 21, 1995 | SESE |
| K946067 | TOTAL CHOLESTEROL, HDL CHOLESTEROL, TRIGLYCERIDES AND GLUCOSE PANEL | Cholestech Corp. | Feb 22, 1995 | SESE |
| K946066 | TOTAL CHOLESTEROL, HDL CHOLESTEROL AND GLUCOSE PANEL | Cholestech Corp. | Feb 22, 1995 | SESE |
| K946065 | TOTAL CHOLESTEROLM HDL CHOLESTEROL AND TRIGLYCERIDES PANEL | Cholestech Corp. | Feb 22, 1995 | SESE |
| K946064 | TOTAL CHOLESTEROL CASSETTE | Cholestech Corp. | Feb 22, 1995 | SESE |
| K946063 | TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL | Cholestech Corp. | Feb 22, 1995 | SESE |
| K943027 | CHOLESTEROL QVET | Prisma Systems | Jan 27, 1995 | SESE |
| K941573 | ROCHE REAGENT | Roche Diagnostic Systems, Inc. | Oct 31, 1994 | SESE |
| K923504 | CHOLESTEROL ENZYMATIC ENDPOINT | Randox Laboratories, Ltd. | Jan 10, 1994 | SESE |
| K935136 | CHOLESTEROL (CHOL) TEST ITEM NO. 65410 | Em Diagnostic Systems, Inc. | Dec 16, 1993 | SESE |
| K934046 | BECKMAN CHOLESTEROL REAGENT | Beckman-Diagnostic Systems Group | Oct 28, 1993 | SESE |
| K914432 | ACCUMETER(R) CHOLESTEROL SELF-TEST | Chemtrak, Inc. | Mar 2, 1993 | SESE |
| K925603 | OLYMPUS CHOLESTEROL REAGENT | Olympus Corp. | Feb 8, 1993 | SESE |
| K924508 | CHOLESTEROL TEST ITEM# 42374/93, 42322/R1 | Em Diagnostic Systems, Inc. | Jan 28, 1993 | SESE |
| K922231 | OLYMPUS CHOLESTEROL REAGENT | Olympus Corp. | Nov 18, 1992 | SESE |
| K923733 | CHOLESTEROL TEST | Em Diagnostic Systems, Inc. | Oct 26, 1992 | SESE |
| K923128 | KING DIAGNOSTICS CHOLESTEROL REAGENT | King Diagnostics, Inc. | Sep 9, 1992 | SESE |
| K922612 | CHOLESTECH LIPID MONITORING SYSTEM, TOTAL CHOLESTE | Cholestech Corp. | Jun 24, 1992 | SESE |
| K914160 | CHOLESTEROL REGEANT SET | Tech Intl. Co. | Jan 30, 1992 | SESE |
| K913565 | ABBOTT QUICKSTART CHOLESTEROL TEST | Em Diagnostic Systems, Inc. | Dec 18, 1991 | SESE |
| K914469 | CHOLESTECH LIPID MONIT SYST, TOTAL CHOL/TRIG PANEL | Cholestech Corp. | Oct 30, 1991 | SESE |
| K912499 | KING DIAGNOSTICS CHOLESTEROL REAGENT STRIP TEST | King Diagnostics, Inc. | Sep 27, 1991 | SESE |
| K912212 | PROACT CHOLESTEROL SYSTEMS | Boehringer Mannheim Corp. | Aug 28, 1991 | SESE |
| K911692 | ENZYMATICS, INC., TOTAL CHOLESTEROL TEST | Enzymatics C/O Burditt,Bowles,Radzius & Ruberry | Aug 16, 1991 | SESE |
| K912136 | CHOLESTECH LIPID MONITORING SYS. | Cholestech Corp. | Jul 30, 1991 | SESE |
| K911578 | CHOLESTECH L.D.X. LIPID ANALYZER, MODIFICATION | Cholestech Corp. | May 15, 1991 | SESE |
| K905405 | CHEMTRAK ACCUMETER CHOLESTEROL TEST | Chemtrak, Inc. | Mar 19, 1991 | SESE |
| K904031 | CHEMA CHOL CHOLESTEROL SYSTEM | Texas Intl. Laboratories, Inc. | Mar 11, 1991 | SESE |
| K905648 | CRP LIPID REAGENT TEST PACK | Cirrus Diagnostics, Inc. | Mar 6, 1991 | SESE |
| K910240 | CHOLESTAT (TM) WHOLE BLOOD CHOLESTEROL TEST | Crystal Diagnostics, Inc. | Feb 26, 1991 | SESE |
| K905145 | ECLIPSE ICA CHOLESTEROL | Biotope, Inc. | Feb 26, 1991 | SESE |
| K903126 | CHOLESTAT(TM) WHOLE BLOOD CHOLESTEROL TEST | Crystal Diagnostics, Inc. | Dec 26, 1990 | SESE |
| K903015 | SYNERMED CHOLESTEROL REAGENT KIT | Synermed, Inc. | Oct 1, 1990 | SESE |
| K902678 | LIQUID STABLE CHOLESTEROL REAGENT KIT | Trace Scientific , Ltd. | Sep 25, 1990 | SESE |
| K902098 | CHOLESTEROL (RATE) REAGENT | Sigma Chemical Co. | Aug 9, 1990 | SESE |
| K901900 | L.D.X LIPID MONITORING SYSTEM | Cholestech Corp. | Jul 24, 1990 | SESE |
| K896467 | SATELLITE C BLOOD CHOLESTEROL MONITORING SYSTEM | Medisense, Inc. | Jun 12, 1990 | SESE |
| K900850 | EMDS CHOLESTEROL (CHO), ITEM NUMBERS 65410 | Em Diagnostic Systems, Inc. | Mar 29, 1990 | SESE |
| K897162 | COULTER CHOLESTEROL REAGENT | Coulter Electronics, Inc. | Mar 29, 1990 | SESE |
| K897036 | IMMUNOTECH CHOLESTEROL TEST | Immunotech Corp. | Mar 6, 1990 | SESE |
| K896239 | COBAS READY CHOLESTEROL REAGENT | Roche Diagnostic Systems, Inc. | Feb 16, 1990 | SESE |
| K895951 | CHOLESTEROL TEST KIT | Elite Technology, Inc. | Feb 16, 1990 | SESE |
| K896073 | CHOLESTEROL, UNIVERSAL ET | Enzyme Technology, Inc. | Dec 12, 1989 | SESE |
| K895158 | VISION WHOLE BLOOD HDL CHOLESTEROL | Abbott Laboratories | Oct 2, 1989 | SESE |
| K893916 | EMDS CHOLESTEROL (CHO), ITEM NUMBER 65410 | Em Diagnostic Systems, Inc. | Aug 28, 1989 | SESE |
| K893479 | CHOLESTEROL REAGENT SET | American Monitor Corp. | Jun 19, 1989 | SESE |
| K891922 | AMRESCO CHOLESTEROL REAGENTS, PROD. # 7325 | American Research Products Co. | Jun 16, 1989 | SESE |
| K892238 | CLA 200 CHEMPRO(R) LIPID ANALYZER | Johnson & Johnson Professionals, Inc. | Jun 7, 1989 | SESE |
| K890334 | TOTAL CHOLESTEROL REAGENT | Alpkem Corp. | May 3, 1989 | SESE |
| K890267 | QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA | Photec Diagnostics, Inc. | Apr 26, 1989 | SESE |
| K890027 | QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD | Photec Diagnostics, Inc. | Apr 26, 1989 | SESE |
| K890990 | EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE | Hichem Diagnostics | Apr 10, 1989 | SESE |
| K884757 | CLINISTAT CHOLESTEROL REAGENT TEST | Heraeus Kulzer, Inc. | Mar 10, 1989 | SESE |
| K885023 | CHOLESTEROL TEST ITEM NUMBER: SR1011 | Em Diagnostic Systems, Inc. | Feb 17, 1989 | SESE |
| K883543 | HDL-CHOLESTEROL PRECIPITATING REAGENT | Medical Analysis Systems, Inc. | Dec 16, 1988 | SESE |
| K880723 | DIMENSION WHOLE BLOOD CHOLESTEROL | Technimed, Inc. | Nov 8, 1988 | SESE |
| K883844 | HI CHEM KINETIC CHOLESTEROL REAGENT #88218 | Hichem Diagnostics | Oct 31, 1988 | SESE |
| K864159 | SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD | Chem-Elec, Inc. | Jun 10, 1988 | SESE |
| K880237 | CHOLESTEROL | Tech-Neal Scientific, Inc. | Apr 28, 1988 | SESE |
| K880311 | WAKO(TM) AUTOKIT CHOLESTEROL | Wako Chemicals USA, Inc. | Mar 1, 1988 | SESE |
| K875131 | (SKD) CHOLESTEROL TEST KIT | Smithkline Diagnostics, Inc. | Mar 1, 1988 | SESE |
| K872930 | BIOTROL CHOLESTEROL ENZYMATIQUE COLOR | Biotrol, USA, Inc. | Aug 21, 1987 | SESE |
| K872575 | HDL CHOLESTEROL REAGENT | Sigma Chemical Co. | Jul 16, 1987 | SESE |
| K872295 | CHOLESTEROL REAGENT | Sigma Diagnostics, Inc. | Jul 16, 1987 | SESE |
| K871676 | ENZYMATIC CHOLESTEROL REAGENT SET | Michclone Associates, Inc. | May 18, 1987 | SESE |
| K870928 | CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS | Electro-Nucleonics Laboratories, Inc. | Apr 22, 1987 | SESE |
| K871260 | CHOLESTEROL DETERMINATION | Biochemical Trade, Inc. | Apr 13, 1987 | SESE |
| K870828 | INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT | Intersect Systems, Inc. | Mar 13, 1987 | SESE |
| K870407 | EASY-TEST CHOLESTEROL(CHOL) NUMBER 16607 | Em Diagnostic Systems, Inc. | Mar 4, 1987 | SESE |
| K863103 | PEG 6,000 | J. D. Assoc. | Jan 13, 1987 | SESE |
| K864081 | U.S. DIAGNOSTICS SERUM CHOLESTEROL TEST | U. S. Diagnostics, Inc. | Dec 4, 1986 | SESE |
| K863927 | CHOLESTEROL | Tech-Co, Inc. | Nov 24, 1986 | SESE |
| K863252 | CHOLESTEROL PROCEDURE | Data Medical Associates, Inc. | Sep 29, 1986 | SESE |
| K863062 | CHOLESTEROL-E (TOTAL) | J. D. Assoc. | Sep 25, 1986 | SESE |
| K863064 | CHOLESTEROL-E (FREE) | J. D. Assoc. | Sep 11, 1986 | SESE |
| K863063 | CHOLESTEROL-E FAST (TOTAL) | J. D. Assoc. | Sep 9, 1986 | SESE |
| K862707 | EMDS(TM) CHOLESTEROL TESTPACK, # 67685/95 | Em Diagnostic Systems, Inc. | Aug 19, 1986 | SESE |
| K862507 | FAST CHOLESTEROL (TOTAL CHOLESTEROL TEST) | Sclavo, Inc. | Jul 16, 1986 | SESE |
| K861659 | CHOLESTEROL PROCEDURE | Data Medical Associates, Inc. | Jun 13, 1986 | SESE |
| K861700 | DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM | E.I. Dupont DE Nemours & Co., Inc. | Jun 11, 1986 | SESE |
| K860717 | ENZYMATIC CHOLESTEROL REAGENT (SINGLE VIAL) | Trace Scientific , Ltd. | Apr 11, 1986 | SESE |
| K855028 | TOTAL CHOLESTEROL REAGENT SET | Sterling Diagnostics, Inc. | Jan 28, 1986 | SESE |
| K854426 | KODAK EKTACHEM HDL CHOLESTEROL KIT | Eastman Kodak Company | Jan 17, 1986 | SESE |
| K855187 | ENZYMATIC CHOLESTROL REAGENT SET | Technostics Intl. | Jan 14, 1986 | SESE |
| K854179 | IN-VITRO TEST FOR THE DETERMINATION OF CHOLESTEROL | Clinical Data, Inc. | Nov 25, 1985 | SESE |
| K853854 | ASTRA SYSTEMS CHOLESTEROL REAGENT | Beckman Instruments, Inc. | Oct 28, 1985 | SESE |
| K853871 | QCA ENZYMATIC CHOLESTEROL | Bd Becton Dickinson Vacutainer Systems Preanalytic | Oct 4, 1985 | SESE |
| K852863 | CHOLESTEROL METHOD | Catachem, Inc. | Jul 23, 1985 | SESE |
| K850390 | CHOLESTEROL TEST SYSTEM | Hans J. Brouwers & Assoc. | Jul 9, 1985 | SESE |
| K852009 | T-CHO REAGENT | Alpkem Corp. | May 30, 1985 | SESE |
| K844655 | PERIDOCHROM CHOLESTEROL HIGH PERFORMANCE | Boehringer Mannheim Corp. | Jan 7, 1985 | SESE |
| K844242 | CHOLESTEROL REAGENT FOR DEMAND ANALYZER | Advanced Biomedical Methods, Inc. | Jan 3, 1985 | SESE |
| K843510 | PDA CHOLESTEROL | Abbott Laboratories | Sep 28, 1984 | SESE |
| K843222 | ENZYMATIC CHOLESTEROL KIT | Livonia Diagnostics, Inc. | Sep 28, 1984 | SESE |
| K843327 | SYSTEMATE CHOLESTEROL 67222 | Em Diagnostic Systems, Inc. | Sep 14, 1984 | SESE |
| K842160 | CHOLESTEROL ASSSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | Aug 17, 1984 | SESE |
| K842320 | TDX REA CHOLESTEROL | Abbott Laboratories | Aug 15, 1984 | SESE |
| K842441 | AXIOM STABLE II CHOLESTEROL TEST | Axiom, Inc. | Jul 25, 1984 | SESE |
| K841182 | MULTIPLE CHEM. MODULE FOR ANALYSIS | Beckman Instruments, Inc. | May 9, 1984 | SESE |
| K841053 | CHOLESTEROL REAGENT SET ENZYMATIC | Medical Specialties, Inc. | May 1, 1984 | SESE |
| K840776 | PARAMAX CHOLESTEROL REAGENT | American Dade | Apr 4, 1984 | SESE |
| K840368 | DURAZYME CHOLESTEROL | American Monitor Corp. | Mar 30, 1984 | SESE |
| K840189 | TOTAL CHOLESTEROL REAGENT SET | Preventive Diagnostics Corp. | Mar 23, 1984 | SESE |
| K832780 | FLOW-PAC SHOLESTEROL REAGENT SET | American Research Products Co. | Oct 14, 1983 | SESE |
| K832158 | CHOLESTEROL HIGH PERFORMANCE-K | Boehringer Mannheim Corp. | Aug 16, 1983 | SESE |
| K831863 | CHOLESTEROL-ENZYMATIC REAGENT SET | Stanbio Laboratory | Jul 22, 1983 | SESE |
| K831700 | MULTICHEM ENZYMATIC CHOLESTEROL SYS | Simmler, Inc. | Jul 19, 1983 | SESE |
| K831687 | WAKO CHOLESTEROL CII | Wako Chemicals USA, Inc. | Jul 18, 1983 | SESE |
| K830761 | WAKO FREE CHOLESTEROL C TEST | Wako Chemicals USA, Inc. | Apr 18, 1983 | SESE |
| K830239 | ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDA | Emd Chemicals, Inc. | Apr 5, 1983 | SESE |
| K830309 | ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDASE | Emd Chemicals, Inc. | Feb 28, 1983 | SESE |
| K823784 | ENZYMATIC CHOLESTEROL (COLORIMETRIC | Analytical & Research Chemicals, Inc. | Jan 14, 1983 | SESE |
| K823500 | CHOLESTEROL REAGENT | Ac Biochemical Laboratories, Inc. | Dec 30, 1982 | SESE |
| K823354 | ULTRACHEM ENZYMATIC CHOLESTEROL OXIDASE | Emd Chemicals, Inc. | Dec 22, 1982 | SESE |
| K823302 | CHOLESTEROL CHOD-PAP TEST | Boehringer Mannheim Corp. | Dec 9, 1982 | SESE |
| K823187 | CHOLESTEROL HIGH SENSIT. REAGENT ENZYM | Rai, Inc. | Nov 22, 1982 | SESE |
| K822417 | NEW ENZYMATIC SINGLE REAGENT FREE CHOL. | Sclavo, Inc. | Oct 21, 1982 | SESE |
| K822418 | ULTRACHEM ENZYMATIC CHOL. OXIDASE | Emd Chemicals, Inc. | Sep 14, 1982 | SESE |
| K821441 | ENZYMATIC CHOLESTERAL OXIDASE #650550 | Emd Chemicals, Inc. | Jun 1, 1982 | SESE |
| K821105 | CHOLESTEZYME-V EIKEN | Syn-Kit, Inc. | May 5, 1982 | SESE |
| K820951 | ENZYMATIC CHOLESTEROL KIT | Anco Medical Reagents & Assoc. | Apr 26, 1982 | SESE |
| K820950 | TOTAL CHOLESTEROL REAGENT SET | Sterling Biochemical, Inc. | Apr 26, 1982 | SESE |
| K820473 | ENZYMATIC CHOLESTEROL REAGENT SYSTEM | American Monitor Corp. | Mar 11, 1982 | SESE |
| K820263 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES | Eastman Kodak Company | Feb 18, 1982 | SESE |
| K813039 | ULTRACHEM E-CHOL, ITEM #65025 | Harleco | Nov 10, 1981 | SESE |
| K812293 | CENTRICHEM CHOLESTEROL REAGENT & CALIBRA | Baker Diagnostics | Aug 31, 1981 | SESE |
| K812100 | SERALYZER | Miles Laboratories, Inc. | Aug 12, 1981 | SESE |
| K812091 | FAST CHOLES-CINET | Sclavo, Inc. | Aug 12, 1981 | SESE |
| K811760 | CHOLESTEROL DETERMINATION | Biorent Diagnostic, Inc. | Jul 10, 1981 | SESE |
| K810673 | ENZYMATIC CHOLESTEROL | Pointe Scientific, Inc., | Mar 31, 1981 | SESE |
| K810405 | CHOLESTEROL REAGENT | Gilford Diagnostics | Feb 26, 1981 | SESE |
| K803287 | CHOLESTEROL REAGENT ENZYMATIC | Rai, Inc. | Jan 16, 1981 | SESE |
| K803254 | LIQUID-STAT REAGENT FOR ASSAY OF CHOLES. | Beckman Instruments, Inc. | Jan 9, 1981 | SESE |
| K802743 | AMES SERA-PAK CHOLESTEROL REAGENT KIT | Miles Laboratories, Inc. | Dec 10, 1980 | SESE |
| K801285 | YSI MODELS 23C & 23CM HDL & TOTAL CHOLES | Yellow Springs Instrument Co., Inc. | Jul 28, 1980 | SESE |
| K801296 | COBAS REAGENT FOR CHOLESTEROL | Roche Analytical Instruments, Inc. | Jun 30, 1980 | SESE |
| K800765 | CENTRIFICHEM CHOLESTEROL | Union Carbide Corp. | Apr 24, 1980 | SESE |
| K800457 | LIQUID-STAT LIQUID REAGENT | Beckman Instruments, Inc. | Mar 20, 1980 | SESE |
| K800199 | LINEAR ENZYMATIC CHOLESTEROL SYSTEM | Simmler, Inc. | Feb 21, 1980 | SESE |
| K792509 | ACA HIGH DENSITY LIPOPROTEIN CHOLES. | E.I. Dupont DE Nemours & Co., Inc. | Jan 11, 1980 | SESE |
| K792478 | CHEM-STRATE CHOLESTEROL | General Diagnostics | Dec 27, 1979 | SESE |
| K791511 | ENZYMATIC REAGENT SET, 4X250 ML. | Macomb Chemical Co. | Sep 4, 1979 | SESE |
| K790947 | AUTO ENZYMATIC CHOLESTEROL | Macomb Chemical Co. | Jun 28, 1979 | SESE |
Top Applicants
- Em Diagnostic Systems, Inc. — 10 clearances
- Cholestech Corp. — 10 clearances
- Polymer Technology Systems, Inc. — 7 clearances
- Boehringer Mannheim Corp. — 7 clearances
- Beckman Instruments, Inc. — 7 clearances
