System, Test, Blood Glucose, Over The Counter
FDA product code NBW · 454 cleared devices
Class 2
Clinical Chemistry
- Regulation
- 21 CFR 862.1345
- Review panel
- CH
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 2001-03-26 – 2026-08-27
NBW
2008-09-18
NBW
2008-09-11
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM110
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NBW
2008-09-05
PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS BGMS:70900-03, 70090-02, G3CH STRIPS
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NBW
2008-08-26
TYSONBIO LINK HEALTH MANAGEMENT SYSTEM
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NBW
2008-08-19
TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81
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NBW
2008-08-13
TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81
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NBW
2008-08-05
U-RIGHT TD-4247 BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2008-07-21
AG-605 BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2008-07-15
ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2008-07-03
IDEAL LIFE POD (MODEL ILP 0001)
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NBW
2008-06-30
DIACHEX BASIC BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX SUPERB BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2008-06-27
IDEAL LIFE GLUCO-MANAGER GMM 0001 BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2008-06-23
CLEVER CHEK AUTO-CODE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4243
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NBW
2008-06-09
ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM
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NBW
2008-06-09
CLEVER CHEK TD-3250C BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
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NBW
2008-04-21
SURECHEK EDGE BLOOD GLUCOSE MONITORING SYSTEM, MODEL SMS-4240
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NBW
2008-04-18
ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2008-04-18
3TEST SUPREME GLUCOSE MONITORING SYSTEM
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NBW
2008-04-08
DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-INFINITY BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2008-04-02
CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4209, -4222, -4225 AND -4226 AND ACHTUNG BLOOD GLUCOSE MONITORING
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NBW
2008-04-01
GLUCOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011E1
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NBW
2008-03-26
MCT-DIABETES
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NBW
2008-03-25
EZ SCAN PLUS BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2008-03-21
EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2008-03-05
PRODIGY VOICE BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2008-03-03
CLEVER CHEK MODEL TD-4232 BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2008-02-29
MAJOR III BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2008-02-28
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM310
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NBW
2008-01-30
WAVESENSE KEYNOTE CODELESS BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2007-12-21
PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4227, CLEVER CHEK TD-4227 BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2007-12-03
EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2
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NBW
2007-10-26
CLEVER CHEK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4209, TD-4222, TD-4225
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NBW
2007-10-05
ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2007-10-03
ADVOCATE REDI-CODE BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4223E; TD-4223F
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NBW
2007-09-27
MODIFICATION TO: JAZZ BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2007-09-20
REVOLUTION TD-4229 BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2007-09-10
PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS
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NBW
2007-08-09
GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2007-07-20
JAZZ BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2007-07-03
MEDAPPS REMOTE PATIENT MONITORING, MODEL MA 100
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NBW
2007-06-29
POLYMAP PWR-08-03
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NBW
2007-06-22
MICRODOT BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2007-06-21
CLEVER CHEK HEALTH CARE SYSTEM SOFTWARE, VERSION 1.0
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NBW
2007-06-13
NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002
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NBW
2007-05-25
ACCU-CHEK PERFORMA SYSTEM
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NBW
2007-05-25
MAXIMED EXICHEK TD-4224 BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2007-05-09
ACCU-CHEK SMART PIX
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NBW
2007-05-07
TRACKRECORD DATA MANAGEMENT SOFTWARE
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NBW
2007-04-30
EASY CHECK BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2007-04-10
FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2007-04-09
ADVOCATE DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223
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NBW
2007-03-15
CLEVER CHEK TD-4230 BLOOD GLUCOSE MONITORING SYSTEM, RD-4230, SURECHEK BLOOD GLUCOSE MONITORING SYSTEM, SMS-4230
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NBW
2007-02-16
ASSURE 4 BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2007-02-16
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2007-02-09
OK METER BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2007-01-31
PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPS
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NBW
2007-01-12
LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067
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NBW
2007-01-12
CLEVER CHEK TD-3213/ CLEVER CHEK TD-3215/ DR. T TD-3216/ CLEVER CHEK TD-3217/ CLEVER CHEK TD-3250 BLOOD GLUCOSE PLUS BLO
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NBW
2006-12-27
EBSENSOR BLOOD GLUCOSE MONITORING SYSTEM, MODEL EB-G
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NBW
2006-12-20
FERRARA BLOOD GLUCOSE MONITORING SYSTEM, MODEL 631100
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NBW
2006-12-14
COPILOT HEALTH MANAGEMENT SYSTEM
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NBW
2006-11-22
CLEVER CHEK TD-4231 AND TD-4223 BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2006-11-22
ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2006-11-13
ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528
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NBW
2006-10-30
GLUCOPLUS BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2006-10-10
DIACHEX BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2006-09-19
EASY CHECK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM; CLEVER CHECK TD-4222, TD-4225, TD-4226 BLOOD GLUCOSE MONITORING SYST
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NBW
2006-09-11
ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080
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NBW
2006-08-16
MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2006-08-11
ACCU-CHEK AVIVA TEST STRIPS
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NBW
2006-07-25
ELEMENT BLOOD GLUCOSE TEST SYSTEM
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NBW
2006-07-13
PRODIGY BLOOD GLUCOSE TEST SYSTEM
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NBW
2006-07-06
ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4207
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NBW
2006-07-06
PRODIGY
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NBW
2006-06-16
EZ SMART-168 GLUCOSE MONITORING SYSTEM
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NBW
2006-06-13
THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM)
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NBW
2006-06-05
GLUCOPACK
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NBW
2006-05-19
ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2006-04-14
G4, MODEL IGM-0004
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NBW
2006-04-12
ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; ASCENSIA MICROFILL REAGENT STRIP, MODEL 7080
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NBW
2006-03-09
FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 11001
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NBW
2006-03-01
EASYMATE BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2006-02-21
MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2006-01-23
LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067
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NBW
2006-01-17
ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2005-12-09
GLUCOSE PILOT
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NBW
2005-12-07
E-SAN BLUETOOTH CRADLE
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NBW
2005-12-07
SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100
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NBW
2005-10-07
GLUCODR SUPERSENSOR SYSTEM
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NBW
2005-10-04
ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002
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NBW
2005-08-09
FREESTYLE CONNECT BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2005-08-08
CLEVER CHECK TD-3215/DR. T TD-3216 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEMS
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NBW
2005-08-05
CLEVER CHEK TD-4225, MODEL TD-4225
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NBW
2005-07-13
3TEST GLUCOSE MONITORING SYSTEM
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NBW
2005-07-12
SIDEKICK BLOOD GLUCOSE TEST SYSTEM
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NBW
2005-06-27
FREESTYLE 600 BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2005-06-02
EZ SMART
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NBW
2005-05-27
PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS
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NBW
2005-04-08
BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2005-03-07
CLEVER CHEK TD-3213
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