FDA 510(k) Applications for Medical Device Product Code "CHH"
(Enzymatic Esterase--Oxidase, Cholesterol)

FDA 510(k) Number Applicant Device Name Decision Date
K130200 ABAXIS, INC. PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM 02/15/2013
K023642 ABAXIS, INC. PICCOLO TOTAL CHOLESTEROL TEST SYSTEM 01/24/2003
K950164 ABAXIS, INC. PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR 04/13/1995
K981476 ABBOTT LABORATORIES CHOL 06/25/1998
K981652 ABBOTT LABORATORIES CHOL 06/29/1998
K843510 ABBOTT LABORATORIES PDA CHOLESTEROL 09/28/1984
K842320 ABBOTT LABORATORIES TDX REA CHOLESTEROL 08/15/1984
K895158 ABBOTT LABORATORIES VISION WHOLE BLOOD HDL CHOLESTEROL 10/02/1989
K823500 AC BIOCHEMICAL LABORATORIES, INC. CHOLESTEROL REAGENT 12/30/1982
K163406 ACON LABORATORIES INC. Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System 07/11/2017
K180504 ACON Laboratories, Inc. Mission Lipid Panel Monitoring System 03/28/2018
K960377 ACTIMED LABORATORIES, INC. ENA-C-T TOTAL CHOLESTEROL TEST 05/02/1996
K981181 ACTIMED LABORATORIES, INC. ENA-C-T TOTAL CHOLESTEROL TEST MODEL F 20000, (PHYSICIAN DIRECTED USE) 08/03/1998
K844242 ADVANCED BIOMEDICAL METHODS, INC. CHOLESTEROL REAGENT FOR DEMAND ANALYZER 01/03/1985
K771586 ADVANCED BIOMEDICAL METHODS, INC. CHOLOPAP-HDL 09/15/1977
K112538 ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT 03/29/2012
K122757 ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT 10/05/2012
K113262 ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT 07/03/2012
K091413 ALFA WASSERMANN, INC. S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG) 10/26/2009
K852009 ALPKEM CORP. T-CHO REAGENT 05/30/1985
K890334 ALPKEM CORP. TOTAL CHOLESTEROL REAGENT 05/03/1989
K840776 AMERICAN DADE PARAMAX CHOLESTEROL REAGENT 04/04/1984
K893479 AMERICAN MONITOR CORP. CHOLESTEROL REAGENT SET 06/19/1989
K840368 AMERICAN MONITOR CORP. DURAZYME CHOLESTEROL 03/30/1984
K770909 AMERICAN MONITOR CORP. ENZYMATIC CHOLESTEROL REAGENT SET 07/14/1977
K820473 AMERICAN MONITOR CORP. ENZYMATIC CHOLESTEROL REAGENT SYSTEM 03/11/1982
K770747 AMERICAN MONITOR CORP. REAGENT SET, CHOLESTEROL, CAT NO. 4024 06/01/1977
K891922 AMERICAN RESEARCH PRODUCTS CO. AMRESCO CHOLESTEROL REAGENTS, PROD. # 7325 06/16/1989
K832780 AMERICAN RESEARCH PRODUCTS CO. FLOW-PAC SHOLESTEROL REAGENT SET 10/14/1983
K823784 ANALYTICAL & RESEARCH CHEMICALS, INC. ENZYMATIC CHOLESTEROL (COLORIMETRIC 01/14/1983
K820951 ANCO MEDICAL REAGENTS & ASSOC. ENZYMATIC CHOLESTEROL KIT 04/26/1982
K042443 ARKRAY, INC. SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL 11/24/2004
K062026 ATHEROTECH, INC. VAP-NT CHOLESTEROL TEST 03/06/2007
K842441 AXIOM, INC. AXIOM STABLE II CHOLESTEROL TEST 07/25/1984
K132031 AXIS-SHIELD POC AS AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL 03/21/2014
K812293 BAKER DIAGNOSTICS CENTRICHEM CHOLESTEROL REAGENT & CALIBRA 08/31/1981
K771582 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC HOLESTEROL DELTA TEST ASSAY 09/13/1977
K853871 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC QCA ENZYMATIC CHOLESTEROL 10/04/1985
K853854 BECKMAN INSTRUMENTS, INC. ASTRA SYSTEMS CHOLESTEROL REAGENT 10/28/1985
K761136 BECKMAN INSTRUMENTS, INC. GLUCOSE ANALYZER 2 W/ CHOLES. REAG KT 01/26/1977
K761089 BECKMAN INSTRUMENTS, INC. GLUCOSE ANALYZER W/ CHOLESTEROL REAG KIT 01/25/1977
K800457 BECKMAN INSTRUMENTS, INC. LIQUID-STAT LIQUID REAGENT 03/20/1980
K803254 BECKMAN INSTRUMENTS, INC. LIQUID-STAT REAGENT FOR ASSAY OF CHOLES. 01/09/1981
K841182 BECKMAN INSTRUMENTS, INC. MULTIPLE CHEM. MODULE FOR ANALYSIS 05/09/1984
K971505 BECKMAN INSTRUMENTS, INC. SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT 06/11/1997
K934046 BECKMAN-DIAGNOSTIC SYSTEMS GROUP BECKMAN CHOLESTEROL REAGENT 10/28/1993
K871260 BIOCHEMICAL TRADE, INC. CHOLESTEROL DETERMINATION 04/13/1987
K811760 BIORENT DIAGNOSTIC, INC. CHOLESTEROL DETERMINATION 07/10/1981
K011970 BIOSAFE LABORATORIES, INC. BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM 09/26/2001
K905145 BIOTOPE, INC. ECLIPSE ICA CHOLESTEROL 02/26/1991
K872930 BIOTROL, USA, INC. BIOTROL CHOLESTEROL ENZYMATIQUE COLOR 08/21/1987
K944458 BOEHRINGER MANNHEIM CORP. ACCU-CHEK INSTANT PLUS CHOLOESTEROL TEST 03/06/1996
K952127 BOEHRINGER MANNHEIM CORP. BOEHRINGER MANNHEIM CHOLESTEROL ASSAY 07/20/1995
K823302 BOEHRINGER MANNHEIM CORP. CHOLESTEROL CHOD-PAP TEST 12/09/1982
K832158 BOEHRINGER MANNHEIM CORP. CHOLESTEROL HIGH PERFORMANCE-K 08/16/1983
K844655 BOEHRINGER MANNHEIM CORP. PERIDOCHROM CHOLESTEROL HIGH PERFORMANCE 01/07/1985
K912212 BOEHRINGER MANNHEIM CORP. PROACT CHOLESTEROL SYSTEMS 08/28/1991
K780635 BOEHRINGER MANNHEIM CORP. REAGENT SET HDL CHOLESTEROL 05/19/1978
K790556 CALBIOCHEM-BEHRING CORP. CHOLESTEROL REAGENT, AUTOMATED ENZYMATIC 05/07/1979
K971345 CAROLINA LIQUID CHEMISTRIES CORP. CHOL OR CHOLESTEROL 05/29/1997
K852863 CATACHEM, INC. CHOLESTEROL METHOD 07/23/1985
K864159 CHEM-ELEC, INC. SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD 06/10/1988
K770780 CHEMETRICS CORP. REAGENTS 07/11/1977
K914432 CHEMTRAK, INC. ACCUMETER(R) CHOLESTEROL SELF-TEST 03/02/1993
K943599 CHEMTRAK, INC. CHEM TRAK ACCUMETER 03/21/1995
K905405 CHEMTRAK, INC. CHEMTRAK ACCUMETER CHOLESTEROL TEST 03/19/1991
K911578 CHOLESTECH CORP. CHOLESTECH L.D.X. LIPID ANALYZER, MODIFICATION 05/15/1991
K914469 CHOLESTECH CORP. CHOLESTECH LIPID MONIT SYST, TOTAL CHOL/TRIG PANEL 10/30/1991
K912136 CHOLESTECH CORP. CHOLESTECH LIPID MONITORING SYS. 07/30/1991
K922612 CHOLESTECH CORP. CHOLESTECH LIPID MONITORING SYSTEM, TOTAL CHOLESTE 06/24/1992
K901900 CHOLESTECH CORP. L.D.X LIPID MONITORING SYSTEM 07/24/1990
K946063 CHOLESTECH CORP. TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL 02/22/1995
K946064 CHOLESTECH CORP. TOTAL CHOLESTEROL CASSETTE 02/22/1995
K946066 CHOLESTECH CORP. TOTAL CHOLESTEROL, HDL CHOLESTEROL AND GLUCOSE PANEL 02/22/1995
K946067 CHOLESTECH CORP. TOTAL CHOLESTEROL, HDL CHOLESTEROL, TRIGLYCERIDES AND GLUCOSE PANEL 02/22/1995
K946065 CHOLESTECH CORP. TOTAL CHOLESTEROLM HDL CHOLESTEROL AND TRIGLYCERIDES PANEL 02/22/1995
K905648 CIRRUS DIAGNOSTICS, INC. CRP LIPID REAGENT TEST PACK 03/06/1991
K854179 CLINICAL DATA, INC. IN-VITRO TEST FOR THE DETERMINATION OF CHOLESTEROL 11/25/1985
K897162 COULTER ELECTRONICS, INC. COULTER CHOLESTEROL REAGENT 03/29/1990
K781013 COULTER ELECTRONICS, INC. ENZYMATIC REAGENT FOR CHOLESTEROL MEAS 07/28/1978
K910240 CRYSTAL DIAGNOSTICS, INC. CHOLESTAT (TM) WHOLE BLOOD CHOLESTEROL TEST 02/26/1991
K903126 CRYSTAL DIAGNOSTICS, INC. CHOLESTAT(TM) WHOLE BLOOD CHOLESTEROL TEST 12/26/1990
K964660 DADE INTL., INC. PARAMAX CHOLESTEROL REAGENT 06/04/1997
K863252 DATA MEDICAL ASSOCIATES, INC. CHOLESTEROL PROCEDURE 09/29/1986
K861659 DATA MEDICAL ASSOCIATES, INC. CHOLESTEROL PROCEDURE 06/13/1986
K946161 DATA MEDICAL ASSOCIATES, INC. DMA TOTAL CHOLESTEROL PROCEDURE 08/23/1995
K971072 DERMA MEDIA LAB., INC. CHOLESTEROL REAGENT 06/20/1997
K842160 DIAGNOSTIC CHEMICALS, LTD. (USA) CHOLESTEROL ASSSAY KIT 08/17/1984
K792509 E.I. DUPONT DE NEMOURS & CO., INC. "ACA" HIGH DENSITY LIPOPROTEIN CHOLES. 01/11/1980
K861700 E.I. DUPONT DE NEMOURS & CO., INC. DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM 06/11/1986
K820263 EASTMAN KODAK COMPANY KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES 02/18/1982
K854426 EASTMAN KODAK COMPANY KODAK EKTACHEM HDL CHOLESTEROL KIT 01/17/1986
K000900 ELAN HOLDINGS, INC. ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS 05/02/2000
K982469 ELAN PHARMA, INC. HICHEM CHOLESTEROL REAGENT KIT 08/19/1998
K870928 ELECTRO-NUCLEONICS LABORATORIES, INC. CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS 04/22/1987
K895951 ELITE TECHNOLOGY, INC. CHOLESTEROL TEST KIT 02/16/1990
K913565 EM DIAGNOSTIC SYSTEMS, INC. ABBOTT QUICKSTART CHOLESTEROL TEST 12/18/1991
K935136 EM DIAGNOSTIC SYSTEMS, INC. CHOLESTEROL (CHOL) TEST ITEM NO. 65410 12/16/1993
K923733 EM DIAGNOSTIC SYSTEMS, INC. CHOLESTEROL TEST 10/26/1992
K885023 EM DIAGNOSTIC SYSTEMS, INC. CHOLESTEROL TEST ITEM NUMBER: SR1011 02/17/1989
K924508 EM DIAGNOSTIC SYSTEMS, INC. CHOLESTEROL TEST ITEM# 42374/93, 42322/R1 01/28/1993
K870407 EM DIAGNOSTIC SYSTEMS, INC. EASY-TEST CHOLESTEROL(CHOL) NUMBER 16607 03/04/1987
K893916 EM DIAGNOSTIC SYSTEMS, INC. EMDS CHOLESTEROL (CHO), ITEM NUMBER 65410 08/28/1989
K900850 EM DIAGNOSTIC SYSTEMS, INC. EMDS CHOLESTEROL (CHO), ITEM NUMBERS 65410 03/29/1990
K862707 EM DIAGNOSTIC SYSTEMS, INC. EMDS(TM) CHOLESTEROL TESTPACK, # 67685/95 08/19/1986
K843327 EM DIAGNOSTIC SYSTEMS, INC. SYSTEMATE CHOLESTEROL 67222 09/14/1984
K821441 EMD CHEMICALS INC. ENZYMATIC CHOLESTERAL OXIDASE #650550 06/01/1982
K830239 EMD CHEMICALS INC. ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDA 04/05/1983
K830309 EMD CHEMICALS INC. ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDASE 02/28/1983
K822418 EMD CHEMICALS INC. ULTRACHEM ENZYMATIC CHOL. OXIDASE 09/14/1982
K823354 EMD CHEMICALS INC. ULTRACHEM ENZYMATIC CHOLESTEROL OXIDASE 12/22/1982
K771067 ENVIRONMENTAL CHEMICAL SPECIALTIES CHOLESTEROL KIT 07/21/1977
K911692 ENZYMATICS C/O BURDITT,BOWLES,RADZIUS & RUBERRY ENZYMATICS, INC., TOTAL CHOLESTEROL TEST 08/16/1991
K896073 ENZYME TECHNOLOGY, INC. CHOLESTEROL, UNIVERSAL ET 12/12/1989
K982118 EXIGENT DIAGNOSTICS, INC. CARESIDE ANALYZER 07/24/1998
K781740 FISHER SCIENTIFIC CO., LLC. REAGENT, HDL 11/22/1978
K992132 GDS TECHNOLOGY, LLC. CHOLESITE TEST SYSTEM 08/20/1999
K792478 GENERAL DIAGNOSTICS CHEM-STRATE CHOLESTEROL 12/27/1979
K810405 GILFORD DIAGNOSTICS CHOLESTEROL REAGENT 02/26/1981
K850390 HANS J. BROUWERS & ASSOC. CHOLESTEROL TEST SYSTEM 07/09/1985
K813039 HARLECO ULTRACHEM E-CHOL, ITEM #65025 11/10/1981
K780523 HARLECO ULTRACHEM ENZYMATIC CHOLESTEROL 65025 05/19/1978
K884757 HERAEUS KULZER, INC. CLINISTAT CHOLESTEROL REAGENT TEST 03/10/1989
K771731 HI CHEM, INC. CHOLAR PRODU&T #17010 10/25/1977
K890990 HICHEM DIAGNOSTICS EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE 04/10/1989
K883844 HICHEM DIAGNOSTICS HI CHEM KINETIC CHOLESTEROL REAGENT #88218 10/31/1988
K111753 HITACHI CHEMICAL DIAGNOSTICS, INC. HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE 12/14/2011
K897036 IMMUNOTECH CORP. IMMUNOTECH CHOLESTEROL TEST 03/06/1990
K771508 INSTRUMENTATION LABORATORY CO. MULTISTAT III CHOLESTEROL TEST 09/13/1977
K870828 INTERSECT SYSTEMS, INC. INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT 03/13/1987
K863064 J. D. ASSOC. CHOLESTEROL-E (FREE) 09/11/1986
K863062 J. D. ASSOC. CHOLESTEROL-E (TOTAL) 09/25/1986
K863063 J. D. ASSOC. CHOLESTEROL-E FAST (TOTAL) 09/09/1986
K863103 J. D. ASSOC. PEG 6,000 01/13/1987
K780783 J.T. BAKER CHEMICAL CO. AUTOZYME CHOLESTEROL-OXIDASE REAGENT KIT 06/06/1978
K080623 JAS Diagnostics, Inc. CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA 11/17/2008
K892238 JOHNSON & JOHNSON PROFESSIONALS, INC. CLA 200 CHEMPRO(R) LIPID ANALYZER 06/07/1989
K923128 KING DIAGNOSTICS, INC. KING DIAGNOSTICS CHOLESTEROL REAGENT 09/09/1992
K912499 KING DIAGNOSTICS, INC. KING DIAGNOSTICS CHOLESTEROL REAGENT STRIP TEST 09/27/1991
K981345 LIFESTREAM DIAGNOSTICS, INC. CHOLESTRON PRO II CHOLESTEROL TEST 10/01/1998
K993096 LIFESTREAM TECHNOLOGIES, INC. PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL MONITOR 12/20/1999
K000610 LIFESTREAM TECHNOLOGIES, INC. RESOLUTION CHOLESTEROL MONITOR 07/21/2000
K843222 LIVONIA DIAGNOSTICS, INC. ENZYMATIC CHOLESTEROL KIT 09/28/1984
K790947 MACOMB CHEMICAL CO. AUTO ENZYMATIC CHOLESTEROL 06/28/1979
K771820 MACOMB CHEMICAL CO. ENZYMATIC CHOLESTEROL 10/19/1977
K791511 MACOMB CHEMICAL CO. ENZYMATIC REAGENT SET, 4X250 ML. 09/04/1979
K780659 MACOMB CHEMICAL CO. HDL CHOLESTEROL 06/13/1978
K072249 MEDICA CORP. EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT 02/20/2008
K883543 MEDICAL ANALYSIS SYSTEMS, INC. HDL-CHOLESTEROL PRECIPITATING REAGENT 12/16/1988
K781721 MEDICAL ANALYSIS SYSTEMS, INC. REAGENT SET, CHOLESTEROL 11/03/1978
K841053 MEDICAL SPECIALTIES, INC. CHOLESTEROL REAGENT SET ENZYMATIC 05/01/1984
K896467 MEDISENSE, INC. SATELLITE C BLOOD CHOLESTEROL MONITORING SYSTEM 06/12/1990
K871676 MICHCLONE ASSOCIATES, INC. ENZYMATIC CHOLESTEROL REAGENT SET 05/18/1987
K802743 MILES LABORATORIES, INC. AMES SERA-PAK CHOLESTEROL REAGENT KIT 12/10/1980
K812100 MILES LABORATORIES, INC. SERALYZER 08/12/1981
K922231 OLYMPUS CORP. OLYMPUS CHOLESTEROL REAGENT 11/18/1992
K925603 OLYMPUS CORP. OLYMPUS CHOLESTEROL REAGENT 02/08/1993
K991083 OTSUKA PHARMACEUTICAL CO., LTD. RLP CHOLESTEROL IMMUNOSEPARATION ASSAY 08/20/1999
K001032 OTSUKA PHARMACEUTICAL CO., LTD. RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY 07/24/2000
K890267 PHOTEC DIAGNOSTICS, INC. QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA 04/26/1989
K890027 PHOTEC DIAGNOSTICS, INC. QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD 04/26/1989
K780331 PIERCE CHEMICAL CO. CHOLESTEROL RAPID SLAT KIT HDL 04/06/1978
K810673 POINTE SCIENTIFIC, INC. ENZYMATIC CHOLESTEROL 03/31/1981
K013173 POLYMER TECHNOLOGY SYSTEMS, INC. BIOSCANNER PLUS; LIPID PANEL TEST STRIPS 10/22/2001
K151545 POLYMER TECHNOLOGY SYSTEMS, INC. CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System 12/22/2016
K990688 POLYMER TECHNOLOGY SYSTEMS, INC. MTM BIOSCANNER C TEST STRIPS 06/24/1999
K981493 POLYMER TECHNOLOGY SYSTEMS, INC. MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220 07/22/1998
K071593 POLYMER TECHNOLOGY SYSTEMS, INC. PTS PANELS CHOL+HDL PANEL TEST STRIPS 10/15/2007
K022898 POLYMER TECHNOLOGY SYSTEMS, INC. PTS PANELS LIPID PANEL TEST STRIPS 09/24/2002
K023558 POLYMER TECHNOLOGY SYSTEMS, INC. PTS PANELS LIPID PANEL TEST STRIPS 11/15/2002
K840189 PREVENTIVE DIAGNOSTICS CORP. TOTAL CHOLESTEROL REAGENT SET 03/23/1984
K943027 PRISMA SYSTEMS CHOLESTEROL QVET 01/27/1995
K823187 RAI, INC. CHOLESTEROL HIGH SENSIT. REAGENT ENZYM 11/22/1982
K803287 RAI, INC. CHOLESTEROL REAGENT ENZYMATIC 01/16/1981
K150654 RANDOX LABORATORIES, LTD. Cholesterol 09/29/2015
K923504 RANDOX LABORATORIES, LTD. CHOLESTEROL ENZYMATIC ENDPOINT 01/10/1994
K972853 REAGENTS APPLICATIONS, INC. CHOLESTEROL RAPID LIQUID REAGENT 09/24/1997
K801296 ROCHE ANALYTICAL INSTRUMENTS, INC. COBAS REAGENT FOR CHOLESTEROL 06/30/1980
K973284 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS INTEGRA HDL-CHOLESTEROL DIRECT 12/18/1997
K896239 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS READY CHOLESTEROL REAGENT 02/16/1990
K941573 ROCHE DIAGNOSTIC SYSTEMS, INC. ROCHE REAGENT 10/31/1994
K051376 Roche Diagnostics ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL, ACCUCHEK INSTANT PLUS GLUCOCOSE 08/23/2005
K031824 ROCHE DIAGNOSTICS CORP. COBAS INTEGRA CHOLESTEROL GEN. 2 07/09/2003
K770265 SCLAVO, INC. CHOLESTEROL TEST 02/25/1977
K812091 SCLAVO, INC. FAST CHOLES-CINET 08/12/1981
K862507 SCLAVO, INC. FAST CHOLESTEROL (TOTAL CHOLESTEROL TEST) 07/16/1986
K822417 SCLAVO, INC. NEW ENZYMATIC SINGLE REAGENT FREE CHOL. 10/21/1982
K902098 SIGMA CHEMICAL CO. CHOLESTEROL (RATE) REAGENT 08/09/1990
K790724 SIGMA CHEMICAL CO. ENZYMATIC DETERMINATION 05/23/1979
K872575 SIGMA CHEMICAL CO. HDL CHOLESTEROL REAGENT 07/16/1987
K790760 SIGMA CHEMICAL CO. REAGENT SYSTEM #350HDL, SIGMA PROCEDURE 05/23/1979
K872295 SIGMA DIAGNOSTICS, INC. CHOLESTEROL REAGENT 07/16/1987
K980667 SIGMA DIAGNOSTICS, INC. INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401) 04/21/1998
K992803 SIGMA DIAGNOSTICS, INC. SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP 09/13/1999
K800199 SIMMLER, INC. LINEAR ENZYMATIC CHOLESTEROL SYSTEM 02/21/1980
K831700 SIMMLER, INC. MULTICHEM ENZYMATIC CHOLESTEROL SYS 07/19/1983
K875131 SMITH KLINE DIAGNOSTICS, INC. (SKD) CHOLESTEROL TEST KIT 03/01/1988
K770483 SMITH KLINE DIAGNOSTICS, INC. CHOLESTEROL REAGENT 06/08/1977
K831863 STANBIO LABORATORY CHOLESTEROL-ENZYMATIC REAGENT SET 07/22/1983
K820950 STERLING BIOCHEMICAL, INC. TOTAL CHOLESTEROL REAGENT SET 04/26/1982
K855028 STERLING DIAGNOSTICS, INC. TOTAL CHOLESTEROL REAGENT SET 01/28/1986
K821105 SYN-KIT, INC. CHOLESTEZYME-V EIKEN 05/05/1982
K903015 SYNERMED, INC. SYNERMED CHOLESTEROL REAGENT KIT 10/01/1990
K914160 TECH INTL. CO. CHOLESTEROL REGEANT SET 01/30/1992
K863927 TECH-CO, INC. CHOLESTEROL 11/24/1986
K880237 TECH-NEAL SCIENTIFIC, INC. CHOLESTEROL 04/28/1988
K880723 TECHNIMED, INC. DIMENSION WHOLE BLOOD CHOLESTEROL 11/08/1988
K855187 TECHNOSTICS INTL. ENZYMATIC CHOLESTROL REAGENT SET 01/14/1986
K904031 TEXAS INTL. LABORATORIES, INC. CHEMA CHOL CHOLESTEROL SYSTEM 03/11/1991
K780638 THE DOW CHEMICAL CO. ACCESSORY HDL CHOLESTEROL REAGENT SET 05/26/1978
K770998 THE DOW CHEMICAL CO. CHOLESTEROL REAGENT SET 06/02/1977
K962890 TRACE SCIENTIFIC LTD. CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST) 09/27/1996
K860717 TRACE SCIENTIFIC LTD. ENZYMATIC CHOLESTEROL REAGENT (SINGLE VIAL) 04/11/1986
K902678 TRACE SCIENTIFIC LTD. LIQUID STABLE CHOLESTEROL REAGENT KIT 09/25/1990
K864081 U. S. DIAGNOSTICS, INC. U.S. DIAGNOSTICS SERUM CHOLESTEROL TEST 12/04/1986
K800765 UNION CARBIDE CORP. CENTRIFICHEM CHOLESTEROL 04/24/1980
K120202 VITAL DIAGNOSTICS PTY. LTD EON CHOLESTEROL REAGENT 07/27/2012
K831687 WAKO CHEMICALS, USA, INC. WAKO CHOLESTEROL CII 07/18/1983
K830761 WAKO CHEMICALS, USA, INC. WAKO FREE CHOLESTEROL C TEST 04/18/1983
K880311 WAKO CHEMICALS, USA, INC. WAKO(TM) AUTOKIT CHOLESTEROL 03/01/1988
K790768 WAKO INTL., INC. WAKO CHOLESTEROL TEST 05/23/1979
K772311 WATERS ASSOC., INC. WISP MODEL 710 01/12/1978
K761263 WORTHINGTON BIOCHEMICAL CORP. CHOLESTEROL AUTOMATED REAGENT 12/29/1976
K780389 WORTHINGTON BIOCHEMICAL CORP. HDL REAGENT SET FOR LIPOPROTEINS 04/19/1978
K801285 YELLOW SPRINGS INSTRUMENT CO., INC. YSI MODELS 23C & 23CM HDL & TOTAL CHOLES 07/28/1980


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