Glucose Dehydrogenase, Glucose
FDA product code LFR · 69 cleared devices
Class 2
Clinical Chemistry
- Regulation
- 21 CFR 862.1345
- Review panel
- CH
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1977-11-22 – 2013-10-11
LFR
2013-10-11
LFR
2013-04-04
NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR
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LFR
2013-02-14
GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS
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LFR
2012-12-20
NOVA ONE BLOOD GLUCOSE MONITOR
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LFR
2012-11-09
PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
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LFR
2012-09-19
GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM
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LFR
2012-07-27
GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM
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LFR
2012-07-26
CONTOUR NEXT BLOOD GLUCOSE METER
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LFR
2012-05-22
TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE MONITORING SYSTEM
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LFR
2012-05-18
EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
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LFR
2012-04-12
U-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEM
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LFR
2012-03-28
EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM
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LFR
2012-03-28
CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER
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LFR
2012-03-28
CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW)
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LFR
2012-03-06
CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM
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LFR
2012-02-16
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS
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LFR
2011-12-23
EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
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LFR
2011-09-21
ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM
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LFR
2011-09-07
EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
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LFR
2011-09-07
ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM
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LFR
2011-07-06
FORA POCT S10/TD-4258 BLOOD GLUCOSE MONITORING SYSTEM
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LFR
2011-05-23
EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017
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LFR
2009-04-16
RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01
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LFR
2007-11-01
THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS
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LFR
2006-09-06
HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT MICROCURETTES MDL 110712
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LFR
2005-09-02
MODIFICATION TO ACCU-CHEK GO SYSTEM
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LFR
2005-05-02
ACCU-CHEK INTEGRA SYSTEM
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LFR
2005-04-27
ACCU-CHEK AVIVA SYSTEM
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LFR
2004-05-20
CLINICAL LABORATORY ANALYZING SYSTEM
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LFR
2004-04-22
ACCU-CHEK GO SYSTEM
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LFR
2003-09-30
SENOVA(R) BLOOD GLUCOSE MONITOR
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LFR
2003-07-03
ACCU-CHEK COMPACT TEST STRIP
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LFR
2002-10-28
MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE TESTING
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LFR
2002-08-16
PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLOGY
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LFR
2001-04-26
ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT COMPACT CONTROLS
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LFR
2001-03-19
ACCU-CHEK INFORM METER
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LFR
2001-03-07
ACCU-CHEK COMFORT CURVE TEST STRIP
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LFR
2000-12-05
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001
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LFR
2000-11-13
SOF-TACT DIABETES MANAGEMENT SYSTEM; SOF-TACT GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS
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LFR
2000-05-05
CONNECT DATA MANAGEMENT SYSTEM
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LFR
2000-02-23
ACCU-CHEK COMPLETE METER
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LFR
2000-01-14
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM
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LFR
1999-12-09
ACCU-CHEK SIMPLICITY SYSTEM
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LFR
1999-02-05
ACCU-CHEK HQ SYSTEM
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LFR
1998-09-03
ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS
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LFR
1998-09-02
ACCU-CHEK COMFORT CURVE TEST STRIP
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LFR
1998-08-28
ACCU-CHECK VOICEMATE
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LFR
1998-05-22
ACCU-CHEK COMFORT CURVE TEST STRIPS
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LFR
1997-12-15
ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS
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LFR
1997-10-09
GLUCOTREND BASIC SYSTEM
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LFR
1996-10-15
HEMOCUE B-GLCOSE SYSTEM
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LFR
1996-08-23
HEMOCUE B-GLUCOSE SYSTEM
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LFR
1996-02-15
ACCU-CHEK ADVANTAGE TEST STRIPS
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LFR
1995-09-06
GLUCOSE TEST ITEM NUMBER 97375/94
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LFR
1995-08-24
ADVANTAGE TEST STRIPS
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LFR
1988-02-02
GLUCOSCOT II BLOOD GLUCOSE TEST SYSTEM
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LFR
1987-12-18
EASY-TEST GLUCOSE (GLUC), ITEM NUMBER 19008
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LFR
1986-04-21
ENZYMATIC GLUCOSE REAGENT SINGLE VIAL GLUCOSE OXID
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LFR
1986-02-11
EMDS GLUCOSE TEST PACK ITEM 67656/95
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LFR
1982-07-06
ULTRACHEM GLUC-DH
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LFR
1982-06-02
ULTRACHEM GLUC-DH, #65048
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LFR
1982-06-02
ULTRACHEM GLUC-DH, #65048
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LFR
1981-12-31
ULTRACHEM GLUC-DH
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LFR
1981-11-10
ULTRACHEM GLUC-DH SET, ITEM #65048
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LFR
1981-05-27
ULTRACHEM GLUC-DH, ITEM NO. 65048
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LFR
1979-08-10
GLUCOSE (GDH) REAGENT
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LFR
1979-08-03
KINETIC DETERMINATION OF UV GLUCOSE
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LFR
1978-12-04
BLOOD SUGAR
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LFR
1977-11-22
UV GLUCOSE DETERM., AUTO CHEM. ANALYZERS
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