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
2011-10-12
NBW
2011-10-11
HEALTH-E-CONNECT SYSTEM
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NBW
2011-09-30
ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE
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NBW
2011-09-27
COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION
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2011-09-21
EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2011-09-16
DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM
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2011-09-15
GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS
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2011-09-02
FORA GD20 BLOOD GLUCOSE MONITORING SYSTEM, U-RUGHT TD-4252D BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2011-08-31
TD-4239 BLOOD GLUCOSE MONITORING SYSTEM AND TD-4239 MULTI BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2011-08-30
TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200
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NBW
2011-08-26
ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI BLOOD GLUCOSE MONITORING SYSTEMS
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NBW
2011-08-09
BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951
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NBW
2011-07-28
TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USE
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NBW
2011-07-15
AG-695 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM/AG-696 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2011-07-01
FORA POCT MANAGMENT SYSTEM
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NBW
2011-06-27
U-RIGHT TD-4279 BLOOD GLUCOSE MONITORING SYSTEM, FORA GD40/TD-4272 BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2011-06-21
EASYMAX T1 SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS10042
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NBW
2011-05-27
CLEVER CHOICE VOICE+ BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2011-05-19
ARK CARE DIABETES MANAGMENT SYSTEM
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NBW
2011-05-13
HEALTH CARE SYSTEM SOFTWARE
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NBW
2011-04-28
AUTOSURE VOICE 3 BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIP
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NBW
2011-02-11
ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2011-01-07
ON CALL PLUS DIABETES MONITORING SOFTWARE
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NBW
2010-12-21
PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE
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NBW
2010-10-18
WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4
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NBW
2010-08-13
ECHO TD-3227 DUAL BLOOD PRESSURE/BLOOD GLUCOSE METER
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NBW
2010-07-13
AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2010-07-09
FORA G30A BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241
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NBW
2010-07-01
EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031
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NBW
2010-06-28
TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277
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NBW
2010-06-18
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM550
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NBW
2010-06-15
FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23
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NBW
2010-06-09
SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2010-06-09
ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER)
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NBW
2010-05-27
GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025
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NBW
2010-05-14
FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring System
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NBW
2010-05-12
EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277
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NBW
2010-05-05
FORA G31A/TD-4256A BLOOD GLUCOSE MONITORING SYSTEM AND FORA G31B/TD-4256B BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2010-04-23
ADVOCATE REDI-CODE DASH BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4276
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NBW
2010-04-08
SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 6277
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NBW
2010-03-15
MODEL TD-3252 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
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NBW
2010-03-12
DIDGET WORLD REPORTS
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NBW
2010-03-02
SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2010-03-02
U-RIGHT TD-4238 AND TD-4246 BLOOD GLUCOSE MONITORING SYSTEM FORA G31 BLOOD GLUCOSE MONITORING SYSTEM, TD-4256 BLOOD GLUC
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NBW
2010-02-25
ADVOCATE REDI-COD DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223
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NBW
2010-02-24
BASESENS BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2010-02-24
EASYMAX V SELF MONITORING BLOOD GLUCOSE SYSTEM
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NBW
2010-02-19
INTOUCH DIABETES
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NBW
2010-02-19
FORA G71A BLOOD GLUCOSE MONITORING SYSTEM, TD-4274 BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2010-02-18
MODELS FORA V30 AND TD-4242 BLOOD GLUCOSE MONITORING SYSTEMS
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NBW
2010-02-05
FORA G72 BLODO GLUCOSE MONITORING SYSTEM/TD-4264 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4264
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NBW
2010-02-04
OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2010-01-19
EBCARRYON BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2010-01-15
NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOS
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NBW
2009-12-24
FORA V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244
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NBW
2009-12-10
NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4251, TD-4252, TD-4253 AND TD-4254
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NBW
2009-12-08
SD CHECK GOLD
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NBW
2009-12-04
DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080
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NBW
2009-12-01
LIPIDPRO SYSTEM
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NBW
2009-11-19
MICRODOT XTRA
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NBW
2009-11-17
GLUCO LAB AUTO CODING, MODEL IGM-0022
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NBW
2009-11-16
SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268
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NBW
2009-10-21
EASYPLUS MINI MASTERDRIVER SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS09009
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NBW
2009-10-09
POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2009-10-02
EOCENE SYSTEM
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NBW
2009-09-18
BLOOD GLUCOSE MONITORING SYSTEM, MODEL FORA G90/TD-4234
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NBW
2009-08-26
CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM
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NBW
2009-08-18
EASYPLUS MINI R13N SELF MONITORING BLOOD GLUCOSE SYSTEM
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NBW
2009-08-14
ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001
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NBW
2009-07-31
GLUCOMANAGER DATA MANAGEMENT SOFTWARE
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NBW
2009-07-17
POLYTEL GMA, MODELS PWR-08-67, PWR-08-07, PWR-08-09
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NBW
2009-07-14
AP-1000 BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2009-07-13
U-RIGHT TD-4227 NO CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4222
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NBW
2009-06-23
FORE V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244, FOREA V12 BLODO GLUCOSE MONITORING SYSTEM, MODEL TD-4247
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NBW
2009-06-04
EASY STEP AND DIACHEX+ PRO BLOOD GLUCOSE MONITORING SYSTEMS
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NBW
2009-05-12
FORA G30 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241
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NBW
2009-05-01
GLUCODR AUTO SYSTEM
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NBW
2009-04-24
CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM; ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2009-04-08
ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2009-03-27
TRUEBALANCE BLOOD GLUCOSE SYSTEM
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NBW
2009-03-26
FORA V12 NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4247
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NBW
2009-03-24
BETACHEK GLUCOSE TEST
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NBW
2009-03-13
SYMCARE DIABETES MANAGEMENT PROGRAM
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NBW
2009-02-27
GLUCODR PLUS SYSTEM, MODEL AGM-3000
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NBW
2009-02-20
G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A
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NBW
2009-02-20
DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM
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NBW
2009-02-10
CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR)
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NBW
2009-02-03
JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381
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NBW
2009-01-23
EASYPLUS MINI R2N SELF MONITORING GLUCOSE TEST SYSTEM
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NBW
2009-01-16
EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008
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NBW
2009-01-16
EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM
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NBW
2009-01-08
MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS
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NBW
2008-12-24
ENVISION BLOOD GLUCOSE TEST SYSTEM
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NBW
2008-12-17
FORA TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM
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NBW
2008-12-04
PRO GLUCOSE TEST STRIP
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NBW
2008-11-26
RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01 STRIPS: 7103-01 (20 COUNT)
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NBW
2008-10-22
ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM
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NBW
2008-10-17
CARESENS BLOOD GLUCOSE MONITORING SYSTEM; CARESENS II METER, MODEL GM505C; CARESENS POP METER, MODEL GM505EA OR GM505EB
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NBW
2008-10-08
GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE
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NBW
2008-10-07
ULTRA TRAK PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-455
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