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
217–240 of 401
Cleared Dec 08, 1986
EXACTECH(TM)
K863468
Travenol Laboratories, S.A.
Chemistry · 91d
Cleared Nov 24, 1986
GLUCOMETER-E
K863102
J. D. Assoc.
Chemistry · 103d
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 Sep 03, 1986
ENZYMATIC BLOOD GLUCOSE
K862721
U. S. Diagnostics, Inc.
Chemistry · 48d
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 Jan 14, 1986
GLUCOSE OXIDASE REAGENT SET
K855194
Technostics Intl.
Chemistry · 19d
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 06, 1985
DIASCAN BLOOD GLUCOSE SELF-MONITOR TEST STRIPS
K851618
Home Diagnostics, Inc.
Chemistry · 110d
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 May 29, 1985
GLU(GOD) REAGENT
K851992
Alpkem Corp.
Chemistry · 22d
Cleared Mar 05, 1985
GLUCOSE - TRINDER- REAGENT
K850364
Sigma Chemical Co.
Chemistry · 34d
Cleared Sep 07, 1984
DIATROL BLOOD GLUCOSE TEST SYS
K842684
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 59d
Cleared Aug 27, 1984
SYSTEMATE GLUCOSE 67215
K843151
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Aug 16, 1984
BOEHRINGER MANNHEIM DIAG. BLOOD GLUCOSE
K842393
Boehringer Mannheim Corp.
Chemistry · 59d
Cleared Jul 19, 1984
GLUCOSE-TRINDER-ADDAY KIT
K842506
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 23d