Glucose Oxidase, Glucose
FDA product code CGA · 392 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
- 1976-10-05 – 2026-05-01
CGA
1993-05-26
CGA
1993-04-20
HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807
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CGA
1992-12-28
GLUCOSE TEST SYSTEM
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CGA
1992-12-23
UNI-CHECK REAGENT STRIP
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CGA
1992-12-17
ELITE TEST STRIPS GLUCOMETER
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CGA
1992-12-03
ONE TOUCH TEST STRIPS
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CGA
1992-11-06
NOVA 12 ANALYZER, MODIFICATION
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CGA
1992-10-14
ACCU-CHEK EASY BLOOD GLUCOSE SYSTEM
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CGA
1992-10-13
ACCUDATA GLUCOSE TEST STATION
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CGA
1992-09-30
IL TEST GLUCOSE, PN 181633-80
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CGA
1992-09-23
GLUCOSE 3
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CGA
1992-09-15
ONE TOUCH IIB BLOOD GLUCOSE METER
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CGA
1992-08-18
QUICK-CHECK II REAGENT STRIP
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CGA
1992-04-14
DIASCAN BLOOD GLUCOSE MONITORING TEST STRIP
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CGA
1992-04-14
ULTRA+ BLOOD GLUCOSE TEST STRIP
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CGA
1992-03-04
FIRST CHOICE
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CGA
1992-01-27
GLUCOSE REAGENT SET
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CGA
1991-11-07
ONE TOUCH(R) II HOSPITAL BLOOD GLUCOSE MONIT SYST
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CGA
1991-10-02
YSI MODEL 2300 STAT PLUS
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CGA
1991-09-10
FIRST CHOICE(TM)
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CGA
1991-07-17
ULTRA BLOOD GLUCOSE MONITORING SYSTEM
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CGA
1991-07-17
VISION BG TEST STRIP
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CGA
1991-05-15
FIRST CHOICE(TM), MODIFICATION
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CGA
1991-05-15
VISION BG MONITOR
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CGA
1991-05-08
HEMOCUE(R) B-GLUCOSE MICROCUVETTE/PHOTOMETER
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CGA
1991-04-12
YSI MODEL 1500 BLOOD GLUCOSE ANALYZER
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CGA
1991-04-03
GLUCOSE V
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CGA
1991-03-29
BIO SCAN-BG(TM
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CGA
1990-12-26
CHOLESTECH LIPID MONITORING SYSTEM, GLUCOSE TEST
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CGA
1990-12-26
GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM
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CGA
1990-10-22
ACCU-CHEK(R) III BLOOD GLUCOSE SYSTEM
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CGA
1990-10-15
ACCU-CHEK (R) EASY (TM) BLOOD GLUCOSE SYSTEM
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CGA
1990-10-15
QUICK CHECK 3 FILM
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CGA
1990-09-13
SYNERMED GLUCOSE REAGENT KIT
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CGA
1990-07-10
MEDISENSE PEN 2/COMPANION 2 BLOOD GLUCOSE SYSTEM
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CGA
1990-03-29
GLUCOMETER GX BLOOD GLUCOSE METER
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CGA
1990-02-26
SATELLITE G BLOOD GLUCOSE MONITORING SYSTEM
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CGA
1989-12-19
AUTOSCAN, AUTOSTRIP AND AUTOCONTROL
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CGA
1989-11-08
ONE TOUCH II METER
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CGA
1989-11-08
QUANTAI UG REAGENT STRIP
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CGA
1989-10-16
COBAS READY GLUCOSE REAGENT
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CGA
1989-10-06
FIRST CHOICE (TM)
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CGA
1989-08-03
INTEGRA(TM) BLOOD GLUCOSE MONITORING SYSTEM
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CGA
1989-07-20
STAT CHEM SYSTEM
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CGA
1989-06-16
GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFILM TEST ST
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CGA
1989-06-12
NEOCHROME(R) III GLUCOSE
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CGA
1989-05-22
YSI MODEL 2300 STAT GLUCOSE AND L-LACTATE ANALYZER
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CGA
1989-04-04
GLUCOFILM TEST STRIPS & CONTROLS/GLUCOMETER 3
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CGA
1989-03-31
ROCHE CHLORIDE ELECTRODE
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CGA
1989-03-15
APEC GLUCOSE ANALYZER
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CGA
1989-02-27
GLUCOSE (GOD) REAGENT
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CGA
1989-02-02
GLUCOSE-SUPER FAST 4983050 AND 4983500
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CGA
1989-01-13
CLINISTAT GLUCOSE REAGENT TEST
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CGA
1989-01-03
GLUCOSE LIQUID AMRESCO #4628300 & 4628001L
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CGA
1988-12-29
VISUAL BLOOD GLUCOSE TEST SYSTEM
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CGA
1988-12-09
ACCUCHEK II FREEDOM(TM) MONITORING SYSTEM
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CGA
1988-08-23
MD STRIPS BG
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CGA
1988-07-12
TRACER(TM) II BLOOD GLUCOSE SYSTEM
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CGA
1988-07-08
QUANTAI BG(TM) REAGENT STRIP
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CGA
1988-04-18
DEXPAD, BLOOD GLUCOSE STRIP
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CGA
1988-04-18
GLUCOSE (TRINDER) CAT. # 220-32
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CGA
1988-04-13
ROMEO(TM) MODEL 1000
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CGA
1987-12-22
GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT
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CGA
1987-10-23
GLUCOSE REAGENT KIT
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CGA
1987-10-20
DIASCAN* BLOOD GLUCOSE SELF-MONITORING TEST STRIPS
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CGA
1987-09-16
GLUCOCHEK S.C. WITH AUDIO OPTION
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CGA
1987-08-31
BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT
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CGA
1987-08-13
NOVOCHECK/CHECKPOINT/CONTROL SOLUTION
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CGA
1987-05-26
GLUCOSE TESTCARD USE W/ILEX PROMPT CLINICAL CH ANA
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CGA
1987-05-12
GLUCOSE ENZYME - COLOR REAGENT SET
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CGA
1987-04-07
MODIFICATION OF ACCU-CHEK II
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CGA
1987-03-13
FAST GLUCOSE
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CGA
1987-03-10
DIMENSION-WBG
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CGA
1987-03-06
GLUCOSE OXIDASE REAGENT
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CGA
1987-02-25
MPX SYSTEM, GLUCOSE TEST SYSTEM
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CGA
1987-02-18
SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI.
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CGA
1987-01-05
ABBOTT SPECTRUM GLUCOSE REAGENT
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CGA
1986-12-08
EXACTECH(TM)
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CGA
1986-12-08
TRACKER SYSTEM
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CGA
1986-12-04
MED-PEN/MED-POINT
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CGA
1986-11-24
GLUCOMETER-E
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CGA
1986-11-13
A-GENT(TM) LIQUID GLUCOSE TRINDER
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CGA
1986-11-13
GLUCOSE OXIDASE
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CGA
1986-11-05
UNIDEX GLUCOSE TEST STRIP
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CGA
1986-09-03
ENZYMATIC BLOOD GLUCOSE
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CGA
1986-08-29
GAMBRO ANALYZ MON GLUCOSE/AM-G & DISP AM-G TUB SET
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CGA
1986-08-04
DIATRON BLOOD GLUCOSE METER
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CGA
1986-08-04
DIAGEM 300 BG REAGENT STRIPS
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CGA
1986-07-02
GLUCOMETER II IMPROVED REFLECTANCE PHOTOMETER
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CGA
1986-07-02
GLUCOMETER M BLOOD GULCOSE METER
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CGA
1986-06-16
DIRECT
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CGA
1986-05-23
GLUCOSE HK PROCEDURE
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CGA
1986-04-24
GLUCOSE OXIDASE PROCEDURE
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CGA
1986-01-14
GLUCOSE OXIDASE REAGENT SET
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CGA
1985-11-25
IN-VITRO TEST FOR THE DETERMINATION OF GLUCOSE
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CGA
1985-11-22
GLUCOSE REAGENT SET (GOD/TRINDER)
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CGA
1985-11-19
CHEMPRO 1000
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CGA
1985-10-03
BETA SCAN TRENDS METER
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CGA
1985-09-16
QCA ENZYMATIC GLUCOSE
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CGA
1985-08-23
GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT
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