Product Code: CGA FDA class 2 21 CFR 862.1345

Glucose Oxidase, Glucose

Clinical Chemistry

The Glucose Oxidase, Glucose test system (product code CGA) is an in-vitro diagnostic device used in clinical chemistry to measure glucose levels in biological fluids using the glucose oxidase enzymatic reaction, a widely used method for blood glucose determination. It is classified as FDA Class 2, representing moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1345 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

View on FDA

510(k)s

400

FEI Numbers

145

Registration Numbers

145

Unique Applicants

192

Years Active

Basic Information

Product Code: CGA
Device Class: FDA class 2
Regulation Number: 862.1345
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 1

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 400 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K210933	YSI 2900C Biochemistry Analyzer	Sep 30, 2024	Substantially Equivalent	YSI Inc.
K220328	EasyStat 300	Jul 26, 2024	Substantially Equivalent	Medica Corporation
K223179	Cholestech LDX System	Sep 20, 2023	Substantially Equivalent	Alere San Diego, Inc.
K223755	i-STAT G cartridge with the i-STAT 1 System	Sep 11, 2023	Substantially Equivalent	Abbott Point of Care Inc.
K223710	i-STAT CG8+ cartridge with the i-STAT 1 System	Jul 28, 2023	Substantially Equivalent	Abbott Point of Care Inc.
K223090	GEM Premier ChemSTAT	Jan 27, 2023	Substantially Equivalent	Instrumentation Laboratory Co
K203549	Nova Primary Glucose Analyzer System	Oct 18, 2022	Substantially Equivalent	Nova Biomedical Corporation
K210958	i-STAT CHEM8+ cartridge with the i-STAT 1 System	Aug 13, 2021	Substantially Equivalent	Abbott Point of Care Inc.
K200349	Stat Profile Prime Plus Analyzer System	Mar 13, 2020	Substantially Equivalent	Nova Biomedical Corporation
K183678	i-STAT CHEM8+ cartridge with the i-STAT 1 System	Feb 07, 2020	Substantially Equivalent	Abbott point of Care, Inc.
K190520	VITROS XT Chemistry Products GLU-Ca Slides	Apr 03, 2019	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K183546	GEM Premier ChemSTAT	Feb 16, 2019	Substantially Equivalent	Instrumentation Laboratory Co.
K182781	PTS Professional Chemistry Kit	Dec 21, 2018	Unknown	Polymer Technology Systems, Inc. d/b/a PTS Diagnostics
K180340	Stat Profile Prime Plus Analyzer System	Sep 26, 2018	Substantially Equivalent	Nova Biomedical Corporation
K163433	VITROS Chemistry Products GLU Slides	Sep 18, 2017	Substantially Equivalent	Ortho Clinical Diagnostics
K163271	i-Stat Alinity System with i-Stat Glucose test	Apr 10, 2017	Substantially Equivalent	Abbott Point of Care, Inc.
K162282	CardioChek Plus Test System, CardioChek Home Test System	Dec 22, 2016	Substantially Equivalent	Polymer Technology Systems, Inc. d/b/a PTS Diagnostics
K160402	GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)	Dec 14, 2016	Substantially Equivalent	Instrumentation Laboratory Co.
K161818	GEM Premier 3000	Sep 14, 2016	Substantially Equivalent	Instrumentation Laboratory Co.
K153692	Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer	Jun 24, 2016	Substantially Equivalent	INFRARED LABORATORY SYSTEMS, LLC (DBA SYNERMED)
K151639	ABL80 FLEX and ABL80 FLEX CO-OX	Dec 07, 2015	Substantially Equivalent	SENDX MEDICAL INC
K142689	GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System	Aug 06, 2015	Substantially Equivalent	Apex BioTechnology Corp.
K151530	CardioChek Plus Test System	Jul 07, 2015	Substantially Equivalent	POLYMER TECHNOLOGY SYSTEMS, INC.
K143750	MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System	May 07, 2015	Substantially Equivalent	APEX BIO TECHNOLOGY CORP
K142302	BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test System	Oct 02, 2014	Substantially Equivalent	Polymer Technology Systems, Inc.
K142336	GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System	Sep 17, 2014	Substantially Equivalent	ARKRAY FACTORY INC.
K133584	IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM	Sep 08, 2014	Substantially Equivalent	EOSHEALTH, INC.
K124021	ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM	Jun 30, 2014	Substantially Equivalent	ARKRAY FACTORY INC.
K131750	AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEM	Mar 06, 2014	Substantially Equivalent	APEX BIOTECHNOLOGY CORP.
K120615	ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE	May 15, 2013	Substantially Equivalent	ALERE SAN DIEGO INC. DBA BIOSITE,INNOVACON,HEMOSEN
K113636	BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)	Mar 08, 2013	Substantially Equivalent	PHILOSYS CO. LTD.
K121706	FORA V10 BLOOD GLUCOSE MONITORING SYSTEM	Jan 14, 2013	Substantially Equivalent	FORA CARE INC.
K122110	ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM	Nov 21, 2012	Substantially Equivalent	ACON LABORATORIES, INC.
K121654	AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION	Sep 05, 2012	Substantially Equivalent	i-SENS, Inc.
K120921	CLEVER CHOICE	Aug 21, 2012	Substantially Equivalent	SIMPLE DIAGNOSTICS, INC.
K120759	CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION	Jun 05, 2012	Substantially Equivalent	i-SENS, Inc.
K113670	ELEMENT BLOOD GLUCOSE MONITORING SYSTEM	May 08, 2012	Substantially Equivalent	INFOPIA CO., LTD
K103230	AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION	Apr 24, 2012	Substantially Equivalent	BESTGEN BIOTECH CORP.
K120448	MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL	Apr 06, 2012	Substantially Equivalent	APEX BIOTECHNOLOGY CORP.
K113547	GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL	Mar 28, 2012	Substantially Equivalent	APEX BIOTECHNOLOGY CORP.
K103116	AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM	Mar 13, 2012	Substantially Equivalent	BESTGEN BIOTECH CORP.
K113208	GAL-1A BLOOD GLUCOSE MONITORING SYSTEM	Jan 26, 2012	Substantially Equivalent	APEX BIOTECHNOLOGY CORP.
K103278	ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION	Oct 28, 2011	Substantially Equivalent	i-SENS, Inc.
K102316	GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM	Oct 07, 2011	Substantially Equivalent	BROADMASTER BIOTECH CORPORATION
K111371	ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM	Oct 06, 2011	Substantially Equivalent	ACON LABORATORIES, INC.
K111728	EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM	Sep 16, 2011	Substantially Equivalent	EPS BIO TECHNOLOGY CORP.
K101204	MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL SOLUTION	Aug 31, 2011	Substantially Equivalent	APEX BIOTECHNOLOGY CORP.
K103842	UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0	Apr 27, 2011	Substantially Equivalent	BECKMAN COULTER, INC.
K101947	IVD-GE02	Mar 16, 2011	Substantially Equivalent	SPHERE MEDICAL LTD.
K103195	I-STAT 1 WIRELESS ANALYZER	Feb 08, 2011	Substantially Equivalent	ABBOTT POINT OF CARE INC.
K101741	DIATRON PICTUS 400	Jan 25, 2011	Substantially Equivalent	DIATRON GROUP
K100525	ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2	Dec 15, 2010	Substantially Equivalent	SEPPIM S.A.S.
K102037	AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPS	Aug 13, 2010	Substantially Equivalent	APEX BIOTECHNOLOGY CORP.
K100405	FORA G90 PERFORM BLOOD GLUCOSE MONITORING SYSTEM	Jul 09, 2010	Substantially Equivalent	TaiDoc Technology Corporation
K100406	FORA V20 BLOOD GLUCOSE MONITORING SYSTEM	May 11, 2010	Substantially Equivalent	TaiDoc Technology Corporation
K100187	EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT	May 05, 2010	Substantially Equivalent	MEDICA CORP.
K093506	CLEVER CHOICE AUTO-CODE PRO BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4267	Apr 01, 2010	Substantially Equivalent	TaiDoc Technology Corporation
K093941	CLEVER CHOICE MINI BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4265	Mar 26, 2010	Substantially Equivalent	TaiDoc Technology Corporation
K091975	INTEGRATED LABORATORY AUTOMATION SOLUTION	Mar 10, 2010	Substantially Equivalent	INTEGRATED LABORATORY AUTOMATION SOLUTIONS, INC.
K082965	DS-A BLOOD GLUCOSE MONITORING SYSTEM	Dec 07, 2009	Substantially Equivalent	ALLIANCE INTERNATIONAL CO., LTD.
K092104	ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM	Nov 24, 2009	Substantially Equivalent	ARKRAY Factory USA, Inc.
K091814	FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM; TD-3263 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTE	Nov 20, 2009	Substantially Equivalent	TaiDoc Technology Corporation
K091102	ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS	Oct 23, 2009	Substantially Equivalent	ARKRAY Factory USA, Inc.
K090109	BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD	Jun 24, 2009	Substantially Equivalent	EPOCAL, INC.
K090043	AUTOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011F9	Apr 09, 2009	Substantially Equivalent	APEX BIOTECHNOLOGY CORP.
K083570	U-RIGHT TD-4249/U-RIGHT TD-4250 BLOOD GLUCOSE MONITORING SYSTEM	Mar 11, 2009	Substantially Equivalent	TaiDoc Technology Corporation
K080636	DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100	Feb 13, 2009	Substantially Equivalent	HUBDIC CO., LTD
K082482	FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD-4254 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4251/TD-4252A/TD-4252B/TD-4254	Jan 30, 2009	Substantially Equivalent	TaiDoc Technology Corporation
K083664	FORA TD-4245 BLOOD GLUCOSE MONITORING SYSTEM, TD-4245	Jan 09, 2009	Substantially Equivalent	TaiDoc Technology Corporation
K082417	GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110	Oct 21, 2008	Substantially Equivalent	ARKRAY Factory USA, Inc.
K082121	EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005	Sep 17, 2008	Substantially Equivalent	EPS BIO TECHNOLOGY CORP.
K081714	FORA TD-3224 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM	Jul 25, 2008	Substantially Equivalent	TaiDoc Technology Corporation
K081609	CLEVER CHEK AND AUDIOCHEK BLOOD GLUCOSE MONITORING SYSTEMS, MODEL TD-4237	Jul 02, 2008	Substantially Equivalent	TaiDoc Technology Corporation
K073416	ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM	Jun 13, 2008	Substantially Equivalent	ARKRAY Factory USA, Inc.
K073648	GLUCOSURE STAR BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90000E1	Apr 10, 2008	Substantially Equivalent	APEX BIOTECHNOLOGY CORP.
K070057	EASYRA CLINICAL CHEMISTRY ANALYZER	Aug 30, 2007	Substantially Equivalent	MEDICA CORP.
K070704	TRILOGY ANALYZER	Jul 13, 2007	Substantially Equivalent	DREW SCIENTIFIC, INC.
K070960	NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM	Jul 11, 2007	Substantially Equivalent	NOVA BIOMEDICAL CORP.
K062799	GLUCO TRACK BLOOD GLUCOSE MONITORING SYSTEM	Feb 06, 2007	Substantially Equivalent	APEX BIOTECHNOLOGY CORP.
K063821	NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM	Jan 24, 2007	Substantially Equivalent	NOVA BIOMEDICAL CORP.
K062892	EUKARE	Jan 22, 2007	Substantially Equivalent	EUMED BIOTECHNOLOGY CO., LTD.
K061431	EASYGLUCO, MODEL IGM-0002 G2	Jan 12, 2007	Substantially Equivalent	US DIAGNOSTICS, INC.
K061528	SELFCHECK GLUCO	Sep 22, 2006	Substantially Equivalent	CARD GUARD SCIENTIFIC SURVIVAL, LTD.
K061992	EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014	Sep 19, 2006	Substantially Equivalent	EPS BIO TECHNOLOGY CORP.
K060345	NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS	Apr 28, 2006	Substantially Equivalent	NOVA BIOMEDICAL CORP.
K053079	ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001	Mar 28, 2006	Substantially Equivalent	HYPOGUARD USA, INC.
K052207	ACCUREX GLUCOSE TEST STRIP	Mar 09, 2006	Substantially Equivalent	INCLINE MEDICAL, LLC
K052121	GEM PREMIER 3000	Oct 21, 2005	Substantially Equivalent	INSTRUMENTATION LABORATORY CO.
K050182	Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEM	Aug 09, 2005	Substantially Equivalent	BIOMEDIX, INC.
K051285	GLUCOLAB BLOOD GLUCOSE MONITORING SYSTEM	Aug 02, 2005	Substantially Equivalent	INFOPIA CO., LTD
K043197	ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM	May 20, 2005	Substantially Equivalent	LIFESCAN, INC.
K043245	EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEM	Apr 29, 2005	Substantially Equivalent	EPS BIO TECHNOLOGY CORP.
K043512	EASYGLUCO IGM-0002 G2	Apr 08, 2005	Substantially Equivalent	AMERICAN HEALTHCARE INC.
K041881	ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100	Mar 25, 2005	Substantially Equivalent	HYPOGUARD USA, INC.
K040974	GLUCOSE OXIDASE, GLUCOSE	Dec 27, 2004	Substantially Equivalent	GENCHEM, INC.
K041427	THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS	Nov 24, 2004	Substantially Equivalent	ARKRAY, INC.
K041478	BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR	Oct 28, 2004	Substantially Equivalent	BECTON DICKINSON
K042015	ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE	Sep 29, 2004	Substantially Equivalent	BAYER HEALTHCARE, DIAGNOSTICS DIVISION
K033627	Q.STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEM	May 21, 2004	Substantially Equivalent	BIOMEDIX, INC.
K033055	GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS	Jan 30, 2004	Substantially Equivalent	DIAMOND DIAGNOSTICS, INC.
K024014	RANDOX RX DAYTONA	Dec 04, 2003	Substantially Equivalent	RANDOX LABORATORIES, LTD.
K031472	ONE TOUCH BASIC/PROFILE/ONE TOUCH II TEST STRIPS	Aug 05, 2003	Substantially Equivalent	LIFESCAN, INC.
K031388	MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM	May 22, 2003	Substantially Equivalent	HYPOGUARD USA, INC.
K024347	EXPRESS BLOOD GLUCOSE MONITORING SYSTEM	Mar 28, 2003	Substantially Equivalent	HYPOGUARD USA, INC.
K024062	ASCENSIA BREEZE BLOOD GLUCOSE METER	Mar 03, 2003	Substantially Equivalent	BAYER CORP.
K023194	SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM	Oct 24, 2002	Substantially Equivalent	LIFESCAN, INC.
K022580	BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM	Oct 09, 2002	Substantially Equivalent	BECTON DICKINSON & CO.
K022158	IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT)	Sep 10, 2002	Substantially Equivalent	INSTRUMENTATION LABORATORY CO.
K021781	EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. PRESTIGE LX AND IQ BLOOD GLUCOSE SYSTEMS	Aug 30, 2002	Substantially Equivalent	CHAY MEDICAL, LLC.
K021943	ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM	Jun 28, 2002	Substantially Equivalent	LIFESCAN, INC.
K020935	HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706	Apr 03, 2002	Substantially Equivalent	HEMOCUE, INC.
K014139	DIABETES ASSISTANT SOFTWARE	Mar 21, 2002	Substantially Equivalent	ROCHE DIAGNOSTICS CORP.
K013342	EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC.	Feb 15, 2002	Substantially Equivalent	CHAY MEDICAL, LLC.
K020232	HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM	Feb 12, 2002	Substantially Equivalent	HYPOGUARD USA, INC.
K011953	WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER LAB. GILICEMIA ENZCA	Dec 21, 2001	Substantially Equivalent	WIENER LABORATORIES S.A.I.C.
K011479	ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM	Nov 30, 2001	Substantially Equivalent	INVERNESS MEDICAL INNOVATIONS, INC.
K013068	BIOSCANNER 2000	Nov 20, 2001	Substantially Equivalent	POLYMER TECHNOLOGY SYSTEMS, INC.
K011233	MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100	May 18, 2001	Substantially Equivalent	APEX BIOTECHNOLOGY CORP.
K010605	ATLAST DATA MANAGEMENT SOFTWARE (DMS)	May 07, 2001	Substantially Equivalent	AMIRA MEDICAL, INC.
K010520	GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS	May 07, 2001	Substantially Equivalent	INSTRUMENTATION LABORATORY CO.
K003346	RANDOX GLUCOSE (GOD/PAP)	Mar 15, 2001	Substantially Equivalent	RANDOX LABORATORIES, LTD.
K002688	PERSONAL GLUCOSE CONTROL CHARTING SYSTEM	Feb 01, 2001	Substantially Equivalent	LXN CORP.
K002624	GLUCOSMART BLOOD GLUCOSE MONITORING SYSTEM	Jan 22, 2001	Substantially Equivalent	APEX BIOTECHNOLOGY CORP.
K002621	GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM	Jan 22, 2001	Substantially Equivalent	APEX BIOTECHNOLOGY CORP.
K003257	EHC400 DESKTOP PATIENT STATION; ECH600 CARE PROVIDER STATION	Dec 22, 2000	Substantially Equivalent	CYBERCARE TECHNOLOGIES, INC.
K001441	SATURN BLOOD GLUCOSE MONITORING TEST STRIP	Dec 18, 2000	Substantially Equivalent	LIFESCAN, INC.
K001387	I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300	Oct 05, 2000	Substantially Equivalent	I-STAT CORP.
K001907	CAMIT DIABETES MANAGEMENT SOFTWARE	Sep 05, 2000	Substantially Equivalent	ROCHE DIAGNOSTICS CORP.
K002134	ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM	Aug 07, 2000	Substantially Equivalent	SELFCARE, INC.
K001092	GENERIC BLOOD GLUCOSE TEST STRIP	Jul 26, 2000	Substantially Equivalent	INBIOS INTL., INC.
K001427	MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM	Jun 02, 2000	Substantially Equivalent	SELFCARE, INC.
K000583	FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM	Mar 17, 2000	Substantially Equivalent	SELFCARE, INC.
K000365	ACCU-CHEK ADVANTAGE METER	Feb 23, 2000	Substantially Equivalent	ROCHE DIAGNOSTICS CORP.
K993837	AVL OPTI CRITICAL CARE ANALYZER	Dec 16, 1999	Substantially Equivalent	AVL SCIENTIFIC CORP.
K993128	HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER]	Nov 23, 1999	Substantially Equivalent	HEALTH HERO NETWORK, INC.
K993632	FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM	Nov 12, 1999	Substantially Equivalent	SELFCARE, INC.
K992988	PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM	Sep 24, 1999	Substantially Equivalent	HOME DIAGNOSTICS, INC.
K991480	EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP	Sep 17, 1999	Substantially Equivalent	SELFCARE, INC.
K991754	GO GLUCOSE MONITORING SYSTEM	Sep 08, 1999	Substantially Equivalent	LXN CORP.
K990942	DUET II GLUCOSE CONTROL MONITORING SYSTEM	Aug 02, 1999	Substantially Equivalent	LXN CORP.
K990649	GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS	Jul 09, 1999	Substantially Equivalent	BAYER CORP.
K983504	PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISION BLOOD GLUCOSE TEST STRIPS, PRECISION XTRA B-KETONE TEST ST	Jul 09, 1999	Substantially Equivalent	MEDISENSE, INC.
K991242	GLUCOMETER ELITE TEST STRIPS	Jun 30, 1999	Substantially Equivalent	BAYER CORP.
K983344	DADE BEHRING QUIKLYTE METABOLYTE CARTRIDGE, MODEL DIMENSION(R) XL OR RXL	Jun 22, 1999	Substantially Equivalent	DADE BEHRING, INC.
K984261	SURESTEP BLOOD GLUCOSE MONITORING SYSTEM	May 21, 1999	Substantially Equivalent	LIFESCAN, INC.
K984527	IN TOUCH DIABETES MANAGEMENT SOFTWARE	Apr 29, 1999	Substantially Equivalent	LIFESCAN, INC.
K990939	FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM	Apr 20, 1999	Substantially Equivalent	SELFCARE, INC.
K984006	GLUCOMETER ELITE XL BLOOD GLUCOSE METER	Mar 18, 1999	Substantially Equivalent	BAYER CORP.
K982076	AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM	Dec 10, 1998	Substantially Equivalent	AMIRA MEDICAL, INC.
K982303	PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST ST	Dec 08, 1998	Substantially Equivalent	MEDISENSE, INC.
K980573	SENSOREX BLOOD GLUCOSE MONITORING SYSTEM	Jul 30, 1998	Substantially Equivalent	CHRONIMED, INC.
K981183	CARESIDE GLUCOSE	May 07, 1998	Substantially Equivalent	EXIGENT DIAGNOSTICS, INC.
K974451	ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM	Jan 26, 1998	Substantially Equivalent	LIFESCAN, INC.
K972669	MTM BIOSCANNER 1000 TEST SYSTEM CONSISTING OF MTM BIOSCANNER 1000 METER, MTM BIOSCANNER G TEST STRIP, NORMAN GLUCOSE CON	Jan 22, 1998	Substantially Equivalent	POLYMER TECHNOLOGY SYSTEMS, INC.
K971653	GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM	Jan 02, 1998	Substantially Equivalent	CLINICAL DIAGNOSTICS, INC.
K972473	ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM DATA DOCK	Dec 16, 1997	Substantially Equivalent	LIFESCAN, INC.
K973140	DUET GLUCOSE CONTROL MONITORING SYSTEM	Oct 31, 1997	Substantially Equivalent	LXN CORP.
K971145	GLUCOSITE TEST SYSTEM	Sep 17, 1997	Substantially Equivalent	GDS TECHNOLOGY, LLC.
K972733	AVL OMNI ANALYZER	Sep 09, 1997	Substantially Equivalent	AVL SCIENTIFIC CORP.
K971812	PRECISION QID BLOOD GLUCOSE TEST STRIP, PRECISION G BLOOD GLUCOSE TEST STRIP	Aug 08, 1997	Substantially Equivalent	MEDISENSE, INC.
K970707	ELECT II BLOOD GLUCOSE MONITORING SYSTEM	Jun 20, 1997	Substantially Equivalent	SELFCARE, INC.
K970556	SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEM	May 12, 1997	Substantially Equivalent	LIFESCAN, INC.
K970781	LIQUID GLUCOSE (OXIDASE) REAGENT SET	Apr 21, 1997	Substantially Equivalent	POINTE SCIENTIFIC, INC.
K963676	PRECISION G BLOOD GLUCOSE TESTING SYSTEM	Feb 20, 1997	Substantially Equivalent	MEDISENSE, INC.
K963544	SUPREME II METER	Feb 20, 1997	Substantially Equivalent	CHRONIMED, INC.
K964630	GLUCOMETER ELITE BLOOD GLUCOSE METER	Feb 10, 1997	Substantially Equivalent	BAYER CORP.
K963500	GLUCOMETER DEX DIABETES CARE SYSTEM	Jan 21, 1997	Substantially Equivalent	BAYER CORP.
K963535	SIGMA DIAGNOSTICS GLUCOSE REAGENT	Jan 17, 1997	Substantially Equivalent	SIGMA DIAGNOSTICS, INC.
K960855	PRESTIGE BLOOD GLUCOSE MONITORING SYSTEM,METER,TEST STRIPS & PRESTIGE HIGH AND LOW GLUCOSE CONTROL	Nov 07, 1996	Substantially Equivalent	HOME DIAGNOSTICS, INC.
K960337	AMD HOME HEALTH MONITORING SYSTEM	Sep 24, 1996	Substantially Equivalent	ADVANCED MEDICAL DEVICES, INC.
K961985	ELECT BLOOD GLUCOSE MONITORIG SYSTEM	Sep 05, 1996	Substantially Equivalent	SELFCARE, INC.
K955107	SAFESTRIP	Aug 16, 1996	Substantially Equivalent	FIREHOUSE MEDICAL, INC.
K962295	PRECISION QID BLOOD GLUCOSE TEST STRIP	Jul 26, 1996	Substantially Equivalent	MEDISENSE, INC.
K943503	CHEMCARD GLUCOSE TEST	Jul 23, 1996	Substantially Equivalent	CHEM-ELEC, INC.
K960053	SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH SYSTEM	Jun 28, 1996	Substantially Equivalent	SELFCARE, INC.
K960034	LXN BLOOD GLUCOSE TEST SYSTEM	Jun 28, 1996	Substantially Equivalent	LXN CORP.
K961337	EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM	Jun 21, 1996	Substantially Equivalent	MEDISENSE, INC.
K955286	EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU)	May 17, 1996	Substantially Equivalent	JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
K944459	ACCU-CHEK INSTANT PLUS G-C/DM BLOOD GLUCOSE MONITORING SYSTEM	Apr 17, 1996	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K951457	GLUCOCHEK POCKETLAB	Feb 22, 1996	Substantially Equivalent	CLINICAL DIAGNOSTICS, INC.
K952875	ACCU-CHEK ALPHA MONITOR & ACCU-CHEK GLUCOSE TEST STRIPS	Nov 21, 1995	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K950628	FIRST CHOICE TEST STRIP	Nov 08, 1995	Substantially Equivalent	POLYMER TECHNOLOGY INTL.
K946166	FIRST CHOICE(TM) TEST STRIP	Nov 08, 1995	Substantially Equivalent	POLYMER TECHNOLOGY INTL.
K952621	EML105 ELECTROLYTE METABOLITE ANALYZER	Oct 17, 1995	Substantially Equivalent	RADIOMETER AMERICA, INC.
K950172	WAKO AUTOKIT GLUCOSE	Oct 05, 1995	Substantially Equivalent	WAKO CHEMICALS, USA, INC.
K951537	GLUCOMETER ELITE M BLOOD GLUCOSE METER	Jul 14, 1995	Substantially Equivalent	BAYER CORP.
K950816	ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM	Jul 03, 1995	Substantially Equivalent	LIFESCAN, INC.
K952279	PRECISION LINK BLOOD GLUCOSE DATA MANAGEMENT SYSTEM	Jun 14, 1995	Substantially Equivalent	MEDISENSE, INC.
K950727	ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEM	Jun 01, 1995	Substantially Equivalent	LIFESCAN, INC.
K942455	LIFESCAN SURESTEP BLOOD GLUCOSE MONITORING SYSTEM	Mar 24, 1995	Substantially Equivalent	LIFESCAN, INC.
K945887	PRECISION Q I D BLOOD GLUCOSE TEST STRIPS	Mar 23, 1995	Substantially Equivalent	MEDISENSE, INC.
K944195	QUICKPRO BLOOD GLUCOSE TESTING SYSTEM	Mar 23, 1995	Substantially Equivalent	MEDISENSE, INC.
K943432	HEMOCUE B-GLUCOSE SYSTEM	Jan 17, 1995	Substantially Equivalent	HEMOCUE, INC.
K940215	GLUCOCHEK	Jan 17, 1995	Substantially Equivalent	CLINICAL DIAGNOSTICS, INC.
K933694	SIGMA GLUCOSE REAGENT	Nov 04, 1994	Substantially Equivalent	SIGMA CHEMICAL CO.
K943241	DMA GLUCOSE (OXIDASE) PROCEDURE	Oct 20, 1994	Substantially Equivalent	DATA MEDICAL ASSOCIATES, INC.
K936212	GLUCOFILM TEST STRIPS	May 10, 1994	Substantially Equivalent	HERAEUS KULZER, INC.
K934892	RELIEF PLUS ONE REAGENT STRIP MODIFICATION	Jan 11, 1994	Substantially Equivalent	DIAGNOSTIC SOLUTIONS, INC.
K934898	GLUCOMETER QA BLOOD GLUCOSE METER MODIFICATION	Dec 07, 1993	Substantially Equivalent	HERAEUS KULZER, INC.
K931196	APEC GLUCOSE ANALYZER	Dec 07, 1993	Substantially Equivalent	APEC, INC.
K926362	GLUCOSTIX REAGENT STRIPS	Nov 10, 1993	Substantially Equivalent	HERAEUS KULZER, INC.
K932727	CHOLESTECH L.D.X. SYSTEM	Nov 09, 1993	Substantially Equivalent	CHOLESTECH CORP.
K930979	ACCU-CHEK ADVANTAGE BLOOD GLUCOSE SYSTEM	Sep 08, 1993	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K926360	GLUCOFILM TEST STRIPS	Sep 08, 1993	Substantially Equivalent	HERAEUS KULZER, INC.
K922137	DIASCAN BLOOD GLUCOSE MONITORING TEST STRIP	Aug 10, 1993	Substantially Equivalent	HOME DIAGNOSTICS, INC.
K922136	ULTRA+ BLOOD GLUCOSE MONITORING TEST STRIP	Aug 10, 1993	Substantially Equivalent	HOME DIAGNOSTICS, INC.
K931310	GLUCOMETER M+ BLOOD GLUCOSE METER	Jun 25, 1993	Substantially Equivalent	HERAEUS KULZER, INC.
K922207	TES-TAPE	Jun 15, 1993	Substantially Equivalent	LILLY RESEARCH LABORATORIES
K931188	CHECKMATE PLUS BLOOD GLUCOSE METER, TEST STRIP,ETC	May 26, 1993	Substantially Equivalent	CASCADE MEDICAL, INC.
K925551	HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807	Apr 20, 1993	Substantially Equivalent	HICHEM DIAGNOSTICS
K923587	GLUCOSE TEST SYSTEM	Dec 28, 1992	Substantially Equivalent	POLYMER TECHNOLOGY CORP.
K924398	UNI-CHECK REAGENT STRIP	Dec 23, 1992	Substantially Equivalent	DIAGNOSTIC SOLUTIONS, INC.
K924499	ELITE TEST STRIPS GLUCOMETER	Dec 17, 1992	Substantially Equivalent	HERAEUS KULZER, INC.
K923544	ONE TOUCH TEST STRIPS	Dec 03, 1992	Substantially Equivalent	LIFESCAN, INC.
K924743	NOVA 12 ANALYZER, MODIFICATION	Nov 06, 1992	Substantially Equivalent	NOVA BIOMEDICAL CORP.
K923048	ACCU-CHEK EASY BLOOD GLUCOSE SYSTEM	Oct 14, 1992	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K924475	ACCUDATA GLUCOSE TEST STATION	Oct 13, 1992	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K922532	IL TEST GLUCOSE, PN 181633-80	Sep 30, 1992	Substantially Equivalent	INSTRUMENTATION LABORATORY CO.
K922035	GLUCOSE 3	Sep 23, 1992	Substantially Equivalent	CARO MED, INC.
K922888	ONE TOUCH IIB BLOOD GLUCOSE METER	Sep 15, 1992	Substantially Equivalent	LIFESCAN, INC.
K921825	QUICK-CHECK II REAGENT STRIP	Aug 18, 1992	Substantially Equivalent	DIAGNOSTIC SOLUTIONS, INC.
K915772	DIASCAN BLOOD GLUCOSE MONITORING TEST STRIP	Apr 14, 1992	Substantially Equivalent	HOME DIAGNOSTICS, INC.
K915770	ULTRA+ BLOOD GLUCOSE TEST STRIP	Apr 14, 1992	Substantially Equivalent	HOME DIAGNOSTICS, INC.
K912580	FIRST CHOICE	Mar 04, 1992	Substantially Equivalent	POLYMER TECHNOLOGY CORP.
K914159	GLUCOSE REAGENT SET	Jan 27, 1992	Substantially Equivalent	TECH INTL. CO.
K913357	ONE TOUCH(R) II HOSPITAL BLOOD GLUCOSE MONIT SYST	Nov 07, 1991	Substantially Equivalent	LIFESCAN, INC.
K913806	YSI MODEL 2300 STAT PLUS	Oct 02, 1991	Substantially Equivalent	YSIS, INC
K912732	FIRST CHOICE(TM)	Sep 10, 1991	Substantially Equivalent	POLYMER TECHNOLOGY CORP.
K912440	ULTRA BLOOD GLUCOSE MONITORING SYSTEM	Jul 17, 1991	Substantially Equivalent	HOME DIAGNOSTICS, INC.
K911624	VISION BG TEST STRIP	Jul 17, 1991	Substantially Equivalent	BRITISH-AMERICAN MEDICAL, INC.
K911792	FIRST CHOICE(TM), MODIFICATION	May 15, 1991	Substantially Equivalent	POLYMER TECHNOLOGY CORP.
K911596	VISION BG MONITOR	May 15, 1991	Substantially Equivalent	BRITISH-AMERICAN MEDICAL, INC.
K911141	HEMOCUE(R) B-GLUCOSE MICROCUVETTE/PHOTOMETER	May 08, 1991	Substantially Equivalent	HEMOCUE, INC.
K910633	YSI MODEL 1500 BLOOD GLUCOSE ANALYZER	Apr 12, 1991	Substantially Equivalent	YELLOW SPRINGS INSTRUMENT CO., INC.
K910573	GLUCOSE V	Apr 03, 1991	Substantially Equivalent	CARO MED, INC.
K910692	BIO SCAN-BG(TM	Mar 29, 1991	Substantially Equivalent	BIO SCAN INSTRUMENT, INC.
K904082	CHOLESTECH LIPID MONITORING SYSTEM, GLUCOSE TEST	Dec 26, 1990	Substantially Equivalent	CHOLESTECH CORP.
K904081	GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM	Dec 26, 1990	Substantially Equivalent	HERAEUS KULZER, INC.
K904292	ACCU-CHEK(R) III BLOOD GLUCOSE SYSTEM	Oct 22, 1990	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K904168	ACCU-CHEK (R) EASY (TM) BLOOD GLUCOSE SYSTEM	Oct 15, 1990	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K903191	QUICK CHECK 3 FILM	Oct 15, 1990	Substantially Equivalent	QUANTAI BIOTRONICS, INC.
K903063	SYNERMED GLUCOSE REAGENT KIT	Sep 13, 1990	Substantially Equivalent	SYNERMED, INC.
K901613	MEDISENSE PEN 2/COMPANION 2 BLOOD GLUCOSE SYSTEM	Jul 10, 1990	Substantially Equivalent	MEDISENSE, INC.
K897015	GLUCOMETER GX BLOOD GLUCOSE METER	Mar 29, 1990	Substantially Equivalent	HERAEUS KULZER, INC.
K896951	SATELLITE G BLOOD GLUCOSE MONITORING SYSTEM	Feb 26, 1990	Substantially Equivalent	MEDISENSE, INC.
K896144	AUTOSCAN, AUTOSTRIP AND AUTOCONTROL	Dec 19, 1989	Substantially Equivalent	CASCADE MEDICAL, INC.
K895911	ONE TOUCH II METER	Nov 08, 1989	Substantially Equivalent	LIFESCAN, INC.
K893661	QUANTAI UG REAGENT STRIP	Nov 08, 1989	Substantially Equivalent	QUANTAI BIOTRONICS, INC.
K895526	COBAS READY GLUCOSE REAGENT	Oct 16, 1989	Substantially Equivalent	ROCHE DIAGNOSTIC SYSTEMS, INC.
K893205	FIRST CHOICE (TM)	Oct 06, 1989	Substantially Equivalent	POLYMER TECHNOLOGY CORP.
K893404	INTEGRA(TM) BLOOD GLUCOSE MONITORING SYSTEM	Aug 03, 1989	Substantially Equivalent	APPRISE, INC.
K891050	STAT CHEM SYSTEM	Jul 20, 1989	Substantially Equivalent	DIAGNOSTIC RESOURCES, INC.
K893117	GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFILM TEST ST	Jun 16, 1989	Substantially Equivalent	BAYER CORP.
K892002	NEOCHROME(R) III GLUCOSE	Jun 12, 1989	Substantially Equivalent	AMERICAN MONITOR CORP.
K891480	YSI MODEL 2300 STAT GLUCOSE AND L-LACTATE ANALYZER	May 22, 1989	Substantially Equivalent	YELLOW SPRINGS INSTRUMENT CO., INC.
K890873	GLUCOFILM TEST STRIPS & CONTROLS/GLUCOMETER 3	Apr 04, 1989	Substantially Equivalent	HERAEUS KULZER, INC.
K890528	ROCHE CHLORIDE ELECTRODE	Mar 31, 1989	Substantially Equivalent	ROCHE DIAGNOSTIC SYSTEMS, INC.
K890524	APEC GLUCOSE ANALYZER	Mar 15, 1989	Substantially Equivalent	AMDEV, INC.
K890336	GLUCOSE (GOD) REAGENT	Feb 27, 1989	Substantially Equivalent	ALPKEM CORP.
K882262	GLUCOSE-SUPER FAST 4983050 AND 4983500	Feb 02, 1989	Substantially Equivalent	AMERICAN RESEARCH PRODUCTS CO.
K884756	CLINISTAT GLUCOSE REAGENT TEST	Jan 13, 1989	Substantially Equivalent	HERAEUS KULZER, INC.
K884909	GLUCOSE LIQUID AMRESCO #4628300 & 4628001L	Jan 03, 1989	Substantially Equivalent	AMERICAN RESEARCH PRODUCTS CO.
K884993	VISUAL BLOOD GLUCOSE TEST SYSTEM	Dec 29, 1988	Substantially Equivalent	DIAGNOSTIC SYSTEMS
K883817	ACCUCHEK II FREEDOM(TM) MONITORING SYSTEM	Dec 09, 1988	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K875049	MD STRIPS BG	Aug 23, 1988	Substantially Equivalent	AMATECH INTERNATIONAL, INC.
K881908	TRACER(TM) II BLOOD GLUCOSE SYSTEM	Jul 12, 1988	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K880703	QUANTAI BG(TM) REAGENT STRIP	Jul 08, 1988	Substantially Equivalent	QUANTAI BIOTRONICS, INC.
K880585	DEXPAD, BLOOD GLUCOSE STRIP	Apr 18, 1988	Substantially Equivalent	MACH DIAG. C/O WICHITA STATE UNIVERSITY
K875211	GLUCOSE (TRINDER) CAT. # 220-32	Apr 18, 1988	Substantially Equivalent	DIAGNOSTIC CHEMICALS, LTD. (USA)
K872889	ROMEO(TM) MODEL 1000	Apr 13, 1988	Substantially Equivalent	DIVA MEDICAL SYSTEMS, INC.
K871835	GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT	Dec 22, 1987	Substantially Equivalent	MILES LABORATORIES, INC.
K873128	GLUCOSE REAGENT KIT	Oct 23, 1987	Substantially Equivalent	A-KEM, INC.
K872505	DIASCAN* BLOOD GLUCOSE SELF-MONITORING TEST STRIPS	Oct 20, 1987	Substantially Equivalent	HOME DIAGNOSTICS, INC.
K871586	GLUCOCHEK S.C. WITH AUDIO OPTION	Sep 16, 1987	Substantially Equivalent	LARKEN INDUSTRIES, INC.
K873117	BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT	Aug 31, 1987	Substantially Equivalent	BIOTROL, USA, INC.
K872049	NOVOCHECK/CHECKPOINT/CONTROL SOLUTION	Aug 13, 1987	Substantially Equivalent	GARID, INC.
K864282	GLUCOSE TESTCARD USE W/ILEX PROMPT CLINICAL CH ANA	May 26, 1987	Substantially Equivalent	MEDICAL DEVICE CONSULTANTS, INC.
K871650	GLUCOSE ENZYME - COLOR REAGENT SET	May 12, 1987	Substantially Equivalent	BIOCHEMICAL TRADE, INC.
K863481	MODIFICATION OF ACCU-CHEK II	Apr 07, 1987	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K870631	FAST GLUCOSE	Mar 13, 1987	Substantially Equivalent	SCLAVO, INC.
K863223	DIMENSION-WBG	Mar 10, 1987	Substantially Equivalent	DIMENSION DIAGNOSTICS
K870616	GLUCOSE OXIDASE REAGENT	Mar 06, 1987	Substantially Equivalent	INTERSECT SYSTEMS, INC.
K864322	MPX SYSTEM, GLUCOSE TEST SYSTEM	Feb 25, 1987	Substantially Equivalent	LIFESCAN, INC.
K864530	SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI.	Feb 18, 1987	Substantially Equivalent	MILES LABORATORIES, INC.
K864224	ABBOTT SPECTRUM GLUCOSE REAGENT	Jan 05, 1987	Substantially Equivalent	ABBOTT LABORATORIES
K863468	EXACTECH(TM)	Dec 08, 1986	Substantially Equivalent	TRAVENOL LABORATORIES, S.A.
K860948	TRACKER SYSTEM	Dec 08, 1986	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K853733	MED-PEN/MED-POINT	Dec 04, 1986	Substantially Equivalent	GARID, INC.
K863102	GLUCOMETER-E	Nov 24, 1986	Substantially Equivalent	J. D. ASSOC.
K863948	A-GENT(TM) LIQUID GLUCOSE TRINDER	Nov 13, 1986	Substantially Equivalent	ABBOTT LABORATORIES
K863926	GLUCOSE OXIDASE	Nov 13, 1986	Substantially Equivalent	TECH-CO, INC.
K862984	UNIDEX GLUCOSE TEST STRIP	Nov 05, 1986	Substantially Equivalent	UNIDEX, INC.
K862721	ENZYMATIC BLOOD GLUCOSE	Sep 03, 1986	Substantially Equivalent	U. S. DIAGNOSTICS, INC.
K860682	GAMBRO ANALYZ MON GLUCOSE/AM-G & DISP AM-G TUB SET	Aug 29, 1986	Substantially Equivalent	GAMBRO, INC.
K855178	DIATRON BLOOD GLUCOSE METER	Aug 04, 1986	Substantially Equivalent	DEXTRON, INC.
K854329	DIAGEM 300 BG REAGENT STRIPS	Aug 04, 1986	Substantially Equivalent	SETON PRODUCTS, INC.
K861303	GLUCOMETER II IMPROVED REFLECTANCE PHOTOMETER	Jul 02, 1986	Substantially Equivalent	MILES LABORATORIES, INC.
K855202	GLUCOMETER M BLOOD GULCOSE METER	Jul 02, 1986	Substantially Equivalent	MILES LABORATORIES, INC.
K852960	DIRECT	Jun 16, 1986	Substantially Equivalent	UNIVERSITY OF WISCONSIN
K861653	GLUCOSE HK PROCEDURE	May 23, 1986	Substantially Equivalent	DATA MEDICAL ASSOCIATES, INC.
K861204	GLUCOSE OXIDASE PROCEDURE	Apr 24, 1986	Substantially Equivalent	DATA MEDICAL ASSOCIATES, INC.
K855194	GLUCOSE OXIDASE REAGENT SET	Jan 14, 1986	Substantially Equivalent	TECHNOSTICS INTL.
K854177	IN-VITRO TEST FOR THE DETERMINATION OF GLUCOSE	Nov 25, 1985	Substantially Equivalent	CLINICAL DATA, INC.
K854335	GLUCOSE REAGENT SET (GOD/TRINDER)	Nov 22, 1985	Substantially Equivalent	STERLING DIAGNOSTICS, INC.
K854260	CHEMPRO 1000	Nov 19, 1985	Substantially Equivalent	SEN TECH MEDICAL CORP.
K851822	BETA SCAN TRENDS METER	Oct 03, 1985	Substantially Equivalent	ORANGE MEDICAL INSTRUMENTS, INC.
K853656	QCA ENZYMATIC GLUCOSE	Sep 16, 1985	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K851703	GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT	Aug 23, 1985	Substantially Equivalent	MILES LABORATORIES, INC.
K851618	DIASCAN BLOOD GLUCOSE SELF-MONITOR TEST STRIPS	Aug 06, 1985	Substantially Equivalent	HOME DIAGNOSTICS, INC.
K851456	ACCU-CHEK II	Aug 01, 1985	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K852130	GLUCOSE(TRINDER) REAGENT	Jun 10, 1985	Substantially Equivalent	SIGMA DIAGNOSTICS, INC.
K851992	GLU(GOD) REAGENT	May 29, 1985	Substantially Equivalent	ALPKEM CORP.
K850364	GLUCOSE - TRINDER- REAGENT	Mar 05, 1985	Substantially Equivalent	SIGMA CHEMICAL CO.
K850257	BCS GLUCOSE COLORIMETRIC TEST	Mar 05, 1985	Substantially Equivalent	BIOCLINICAL SYSTEMS, INC.
K843528	GLUCOSE OXIDASE ENZYMATIC REAGENT SET	Sep 28, 1984	Substantially Equivalent	LIVONIA DIAGNOSTICS, INC.
K843003	GLUCOSE AUTO& STAT GA-1120	Sep 28, 1984	Substantially Equivalent	KYOTO DIAGNOSTICS, INC.
K842684	DIATROL BLOOD GLUCOSE TEST SYS	Sep 07, 1984	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K843151	SYSTEMATE GLUCOSE 67215	Aug 27, 1984	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K841369	BETA SCAN DRYSTIX	Aug 23, 1984	Substantially Equivalent	ORANGE MEDICAL INSTRUMENTS, INC.
K842393	BOEHRINGER MANNHEIM DIAG. BLOOD GLUCOSE	Aug 16, 1984	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K842506	GLUCOSE-TRINDER-ADDAY KIT	Jul 19, 1984	Substantially Equivalent	DIAGNOSTIC CHEMICALS, LTD. (USA)
K842221	WAKO GLUCOSE C	Jul 12, 1984	Substantially Equivalent	WAKO PURE CHEMICAL INDUSTRIES, LTD.
K842207	WAKO B.G. PRETEST STRIPS	Jun 26, 1984	Substantially Equivalent	HEALTHDYNE, INC.
K840962	REFLOCHECK-S	Jun 22, 1984	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K840484	DIATRON EASYTEST BLOOD GLUCOSE MONI	Jun 22, 1984	Substantially Equivalent	MEDIVIX, INC.
K841055	GLUCOSE ENZYMATIC REAGENT SET	May 01, 1984	Substantially Equivalent	MEDICAL SPECIALTIES, INC.
K834271	REFLOCHECK & GLUCOSE TEST STRIP SYS	Feb 13, 1984	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K833257	WAKO GLUCOSE C	Dec 08, 1983	Substantially Equivalent	WAKO CHEMICALS, USA, INC.
K832691	BETA SCAN REAGENT STRIP	Nov 14, 1983	Substantially Equivalent	ORANGE MEDICAL INSTRUMENTS, INC.
K833069	TDX GLUCOSE	Nov 07, 1983	Substantially Equivalent	ABBOTT LABORATORIES
K831194	GLUCOKEY	Oct 31, 1983	Substantially Equivalent	ULSTER SCIENTIFIC, INC.
K832926	ENZYMATIC GLUCOSE DETERMINATION	Oct 28, 1983	Substantially Equivalent	SERAGEN DIAGNOSTICS, INC.
K832159	UNITIZED ENZYMATIC GLUCOSE TEST SET	Aug 16, 1983	Substantially Equivalent	STANBIO LABORATORY
K831989	VISIDEX II REAGENT STRIPS	Aug 08, 1983	Substantially Equivalent	MILES LABORATORIES, INC.
K831634	GLUCOSE REAGENT B6360-11	Jul 19, 1983	Substantially Equivalent	AMERICAN SCIENTIFIC PRODUCTS
K831624	GLUCOSE REAGENT KITS-B6370-10A	Jul 06, 1983	Substantially Equivalent	AMERICAN SCIENTIFIC PRODUCTS
K831411	GLUCOSE OXIDASE/PEROXIDASE TEST	Jul 06, 1983	Substantially Equivalent	KING DIAGNOSTICS, INC.
K823474	ENZYMATIC GLUCOSE DETERMINATION	Dec 30, 1982	Substantially Equivalent	THE DOW CHEMICAL CO.
K822976	HYPOCOUNT A	Nov 16, 1982	Substantially Equivalent	PHARMAQUEST CORP.
K822958	LANCER MSH GLUCOSE DIAG. KIT	Nov 05, 1982	Substantially Equivalent	SHERWOOD MEDICAL CO.
K822699	GLUCOSCAN METER MODEL II	Nov 05, 1982	Substantially Equivalent	LIFESCAN, INC.
K822486	HOME BLOOD GLUCOSE MONITOR	Nov 05, 1982	Substantially Equivalent	PHARMAQUEST CORP.
K822697	GLUCOSCAN TEST STRIPS	Sep 30, 1982	Substantially Equivalent	LIFESCAN, INC.
K821204	GLUCOSE(ENZYMATIC) REAGENT SET	Jul 22, 1982	Substantially Equivalent	OMEGA MEDICAL ELECTRONICS
K821192	YSI #24 & 24M GLUCOSE ANALYZERS	Jun 14, 1982	Substantially Equivalent	YELLOW SPRINGS INSTRUMENT CO., INC.
K821247	ACCUDEX REAGENT STRIPS	May 21, 1982	Substantially Equivalent	MILES LABORATORIES, INC.
K821179	VISIDEX REAGENT STRIPS	May 14, 1982	Substantially Equivalent	MILES LABORATORIES, INC.
K821091	ACCUCHEK BG.	May 14, 1982	Substantially Equivalent	BIODYNAMICS CORP.
K820465	CHEMSTRIP UG	Mar 11, 1982	Substantially Equivalent	BIODYNAMICS CORP.
K813555	GLUCOSE ENZYME-COLOR REAGENT SET	Jan 18, 1982	Substantially Equivalent	BIORENT DIAGNOSTIC, INC.
K813412	GLUCOSE ENZYME-COLOR REAGENT SET	Dec 31, 1981	Substantially Equivalent	DIAGNOSTIC SPECIALTIES
K813370	ELECTROLYTE GEL	Dec 22, 1981	Substantially Equivalent	HI CHEM, INC.
K812866	ASTRA REAGENT CONCENTRATE SYSTEM	Dec 17, 1981	Substantially Equivalent	NOBEL SCIENTIFIC INDUSTRIES, INC.
K813168	LIQUIZYME GLUCOSE REAGENT	Dec 03, 1981	Substantially Equivalent	AMERICAN RESEARCH PRODUCTS CO.
K812258	ACR ENZYMATIC GLUCOSE OXIDASE	Aug 31, 1981	Substantially Equivalent	HARLECO
K811165	GLUCOSE OXIDASE RATE REAGENT	Aug 13, 1981	Substantially Equivalent	CHEM-ELEC, INC.
K811882	KING DIAGNOSTICS GLUCOSE TEST	Jul 23, 1981	Substantially Equivalent	KING DIAGNOSTICS, INC.
K811592	LIQUIZYME SINGLE SOLUTION GLUCOSE REAG	Jul 01, 1981	Substantially Equivalent	AMRESCO, INC.
K811392	AMES SERA-PAK GLUCOSE REAGENT	May 29, 1981	Substantially Equivalent	MILES LABORATORIES, INC.
K811074	GLUCOSE REAGENT-ENZYMATIC-COLOR 500	Apr 29, 1981	Substantially Equivalent	REAGENTS APPLICATIONS, INC.
K810993	GLUCOSCAN TEST STRIPS	Apr 29, 1981	Substantially Equivalent	LIFESCAN, INC.
K810674	GLUCOSE OXIDASE	Mar 31, 1981	Substantially Equivalent	POINTE SCIENTIFIC, INC.
K810639	SERALYZER SYSTEM	Mar 31, 1981	Substantially Equivalent	MILES LABORATORIES, INC.
K810567	GERMCO TEST R GLUCOSE TEST KIT	Mar 13, 1981	Substantially Equivalent	FERMCO BIOCHEMICS, INC.
K801897	GLUCOSE DIAGNOSTIC REAGENT	Oct 10, 1980	Substantially Equivalent	CONNECTICUT DIAGNOSTICS, LTD.
K801600	GLUCOSE (TRINDER) REAGENT	Aug 27, 1980	Substantially Equivalent	GILFORD DIAGNOSTICS
K801663	SERALYZER GLUCOSE REAGENT STRIPS	Aug 20, 1980	Substantially Equivalent	MILES LABORATORIES, INC.
K800687	REAGENT FOR DETERM. GLUCOSE IN H/SERUM	May 28, 1980	Substantially Equivalent	DIAGNOSTIC SOLUTIONS, INC.
K801071	LANCER GLUCOSE RATE REAGENT KIT	May 23, 1980	Substantially Equivalent	SHERWOOD MEDICAL INDUSTRIES
K800589	GLUCOSE OXIDASE REAGENT	Apr 04, 1980	Substantially Equivalent	NOBEL SCIENTIFIC INDUSTRIES, INC.
K800200	LINEAR ENZYMATIC GLUCOSE SYSTEM	Feb 21, 1980	Substantially Equivalent	SIMMLER, INC.
K800070	GLUCOSE OXIDASE REAGENT KIT	Feb 05, 1980	Substantially Equivalent	FISHER SCIENTIFIC CO., LLC.
K792534	NEOCHROME II GLUCOSE, #4044	Jan 16, 1980	Substantially Equivalent	AMERICAN MONITOR CORP.
K792398	ELVI GLUCOSE	Dec 07, 1979	Substantially Equivalent	VOLU SOL MEDICAL INDUSTRIES
K791989	TECHNICON C202 SYSTEM	Oct 17, 1979	Substantially Equivalent	TECHNICON INSTRUMENTS CORP.
K791869	GLUCOSE OXIDASE (FRINDER) KIT	Oct 01, 1979	Substantially Equivalent	MID TECH, INC.
K791669	GLUCOSE OXIDASE REAGENT SET	Sep 24, 1979	Substantially Equivalent	MACOMB CHEMICAL CO.
K791685	GLUCOSE REAGENT	Sep 17, 1979	Substantially Equivalent	HI CHEM, INC.
K791066	GLUCOSE GOD-PAP TRINDER METHOD TEST KIT	Sep 04, 1979	Substantially Equivalent	FERMCO BIOCHEMICS, INC.
K781945	GLUCOSE OXIDASE REAGENT	Jan 17, 1979	Substantially Equivalent	FERMCO BIOCHEMICS, INC.
K781342	GLUCOSE TEST	Aug 31, 1978	Substantially Equivalent	WAKO INTL., INC.
K781307	GLUCOSE DETERM. KIT	Aug 31, 1978	Substantially Equivalent	ANALYTICAL & RESEARCH CHEMICALS, INC.
K781075	STATTEK-GLUCOSE LOW LEVEL	Aug 14, 1978	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K780393	BIOSTATOR GLUCOSE ANALYZER	Jun 19, 1978	Substantially Equivalent	MILES LABORATORIES, INC.
K780512	AUTO/STAT KIT	May 03, 1978	Substantially Equivalent	PIERCE CHEMICAL CO.
K772308	AUTOZYME GLUCOSE OXIDASE (TRINDER)	Mar 03, 1978	Substantially Equivalent	J.T. BAKER CHEMICAL CO.
K780093	GLUCOSE REAGENT FOR GLUCOSE ANALYZER	Feb 13, 1978	Substantially Equivalent	HARLECO
K771754	GLUCOSE REAGENT FOR GLUC. ANALYZER	Oct 18, 1977	Substantially Equivalent	HARLECO
K771471	MULTISTAT III GLUCOSE TEST	Sep 12, 1977	Substantially Equivalent	INSTRUMENTATION LABORATORY CO.
K771059	DIAG. OZYRATE GLUCOSE REAG. SET	Jul 21, 1977	Substantially Equivalent	J.T. BAKER CHEMICAL CO.
K771000	TRENDAR	Jul 15, 1977	Substantially Equivalent	HI CHEM, INC.
K771001	STATZYME GLUCOSE	Jul 11, 1977	Substantially Equivalent	WORTHINGTON BIOCHEMICAL CORP.
K770317	GLUCOSE TRINDER, ENZYMATIC	Mar 30, 1977	Substantially Equivalent	ICN PHARMACEUTICALS, INC.
K770200	GO/HPO-GLUCOSE REAGENT (TRINDER)	Feb 23, 1977	Substantially Equivalent	BECKMAN INSTRUMENTS, INC.
K761148	REFLOMAT/REFLOTEST SYSTEM	Feb 11, 1977	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K761060	GLUCOSE ANALYZER 2	Jan 25, 1977	Substantially Equivalent	BECKMAN INSTRUMENTS, INC.
K761181	GLUCOSE OXIDASE REAGENT SYSTEM	Dec 13, 1976	Substantially Equivalent	NOBEL SCIENTIFIC INDUSTRIES, INC.
K761154	GLUCOSE OXIDASE REAG FOR BECKMAN ANALYZ	Dec 09, 1976	Substantially Equivalent	ADVANCED BIOMEDICAL METHODS, INC.
K761153	GLUC OPAP, IN VITRO DIAG. FOR GLUCOSE	Dec 09, 1976	Substantially Equivalent	ADVANCED BIOMEDICAL METHODS, INC.
K760347	SET, TRINDER GLUCOSE	Oct 05, 1976	Substantially Equivalent	PRINCETON BIOMEDIX

FEI Numbers

This FDA classification entry is associated with 145 FEI numbers. Click on an entry to view related FDA registrations.

1000115322: 6 registrations

1000125596: 34 registrations

1000136573: 169 registrations

1000206808: 104 registrations

1000305840: 46 registrations

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1217183: 82 registrations

1219029: 104 registrations

1219913: 131 registrations

1220649: 82 registrations

1220972: 44 registrations

1550101: 3 registrations

1616487: 87 registrations

1825396: 5 registrations

1827821: 149 registrations

1832216: 187 registrations

1832816: 43 registrations

2027541: 4 registrations

2050010: 124 registrations

2050012: 131 registrations

2245578: 23 registrations

2250051: 152 registrations

2431530: 77 registrations

2432235: 462 registrations

2939301: 5 registrations

2939693: 17 registrations

3000210620: 59 registrations

3001058982: 13 registrations

3001451797: 67 registrations

3002637618: 60 registrations

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3002671736: 19 registrations

3002698769: 25 registrations

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3003116995: 8 registrations

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3003366417: 6 registrations

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3003795116: 46 registrations

3003902721: 18 registrations

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3005644014: 6 registrations

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3006198300: 142 registrations

3006305917: 28 registrations

3006371704: 52 registrations

3006493142: 3 registrations

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3008789114: 19 registrations

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3009129531: 9 registrations

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3009473156: 6 registrations

3010097171: 305 registrations

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3010605677: 176 registrations

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3010622184: 2 registrations

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3011213605: 15 registrations

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3011989923: 99 registrations

3012104670: 72 registrations

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3012391774: 4 registrations

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3012963943: 138 registrations

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3013223546: 13 registrations

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3015109923: 10 registrations

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3016525500: 6 registrations

3016774562: 28 registrations

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3020978007: 22 registrations

3021186226: 17 registrations

3021611414: 2 registrations

3021841051: 48 registrations

3022147580: 13 registrations

3023162659: 45 registrations

3026229484: 1 registration

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3026408938: 290 registrations

3030186688: 20 registrations

3030978471: 10 registrations

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5864: 44 registrations