CGA · Class II · 21 CFR 862.1345

FDA Product Code CGA: Glucose Oxidase, Glucose

Leading manufacturers include Lifescan, Inc., Boehringer Mannheim Corp. and Apex BioTechnology Corp..

401
Total
401
Cleared
129d
Avg days
1976
Since
401 devices
121–144 of 401
Cleared Apr 18, 1988
GLUCOSE (TRINDER) CAT. # 220-32
K875211
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 122d
Cleared Dec 22, 1987
GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT
K871835
Miles Laboratories, Inc.
Chemistry · 225d
Cleared Aug 31, 1987
BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT
K873117
Biotrol, USA, Inc.
Chemistry · 21d
Cleared Apr 07, 1987
MODIFICATION OF ACCU-CHEK II
K863481
Boehringer Mannheim Corp.
Chemistry · 210d
Cleared Mar 13, 1987
FAST GLUCOSE
K870631
Sclavo, Inc.
Chemistry · 28d
Cleared Feb 25, 1987
MPX SYSTEM, GLUCOSE TEST SYSTEM
K864322
Lifescan, Inc.
Chemistry · 114d
Cleared Feb 18, 1987
SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI.
K864530
Miles Laboratories, Inc.
Chemistry · 93d
Cleared Jan 05, 1987
ABBOTT SPECTRUM GLUCOSE REAGENT
K864224
Abbott Laboratories
Chemistry · 69d
Cleared Dec 08, 1986
TRACKER SYSTEM
K860948
Boehringer Mannheim Corp.
Chemistry · 271d
Cleared Dec 08, 1986
EXACTECH(TM)
K863468
Travenol Laboratories, S.A.
Chemistry · 91d
Cleared Nov 13, 1986
GLUCOSE OXIDASE
K863926
Tech-Co, Inc.
Chemistry · 36d
Cleared Nov 13, 1986
A-GENT(TM) LIQUID GLUCOSE TRINDER
K863948
Abbott Laboratories
Chemistry · 34d
Cleared Aug 29, 1986
GAMBRO ANALYZ MON GLUCOSE/AM-G & DISP AM-G TUB SET
K860682
Gambro, Inc.
Chemistry · 185d
Cleared Jul 02, 1986
GLUCOMETER M BLOOD GULCOSE METER
K855202
Miles Laboratories, Inc.
Chemistry · 188d
Cleared Jul 02, 1986
GLUCOMETER II IMPROVED REFLECTANCE PHOTOMETER
K861303
Miles Laboratories, Inc.
Chemistry · 86d
Cleared May 23, 1986
GLUCOSE HK PROCEDURE
K861653
Data Medical Associates, Inc.
Chemistry · 23d
Cleared Apr 24, 1986
GLUCOSE OXIDASE PROCEDURE
K861204
Data Medical Associates, Inc.
Chemistry · 24d
Cleared Nov 25, 1985
IN-VITRO TEST FOR THE DETERMINATION OF GLUCOSE
K854177
Clinical Data, Inc.
Chemistry · 41d
Cleared Nov 22, 1985
GLUCOSE REAGENT SET (GOD/TRINDER)
K854335
Sterling Diagnostics, Inc.
Chemistry · 25d
Cleared Sep 16, 1985
QCA ENZYMATIC GLUCOSE
K853656
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 13d
Cleared Aug 23, 1985
GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT
K851703
Miles Laboratories, Inc.
Chemistry · 121d
Cleared Aug 01, 1985
ACCU-CHEK II
K851456
Boehringer Mannheim Corp.
Chemistry · 112d
Cleared Jun 10, 1985
GLUCOSE(TRINDER) REAGENT
K852130
Sigma Diagnostics, Inc.
Chemistry · 25d
Cleared Mar 05, 1985
GLUCOSE - TRINDER- REAGENT
K850364
Sigma Chemical Co.
Chemistry · 34d