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
193–216 of 401
Cleared Oct 06, 1989
FIRST CHOICE (TM)
K893205
Polymer Technology Corp.
Chemistry · 163d
Cleared Jun 16, 1989
GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFILM TEST ST
K893117
Bayer Corp.
Chemistry · 52d
Cleared Jun 12, 1989
NEOCHROME(R) III GLUCOSE
K892002
American Monitor Corp.
Chemistry · 76d
Cleared May 22, 1989
YSI MODEL 2300 STAT GLUCOSE AND L-LACTATE ANALYZER
K891480
Yellow Springs Instrument Co., Inc.
Chemistry · 66d
Cleared Apr 04, 1989
GLUCOFILM TEST STRIPS & CONTROLS/GLUCOMETER 3
K890873
Heraeus Kulzer, Inc.
Chemistry · 42d
Cleared Mar 31, 1989
ROCHE CHLORIDE ELECTRODE
K890528
Roche Diagnostic Systems, Inc.
Chemistry · 57d
Cleared Feb 27, 1989
GLUCOSE (GOD) REAGENT
K890336
Alpkem Corp.
Chemistry · 35d
Cleared Feb 02, 1989
GLUCOSE-SUPER FAST 4983050 AND 4983500
K882262
American Research Products Co.
Chemistry · 247d
Cleared Jan 13, 1989
CLINISTAT GLUCOSE REAGENT TEST
K884756
Heraeus Kulzer, Inc.
Chemistry · 60d
Cleared Jan 03, 1989
GLUCOSE LIQUID AMRESCO #4628300 & 4628001L
K884909
American Research Products Co.
Chemistry · 41d
Cleared Dec 09, 1988
ACCUCHEK II FREEDOM(TM) MONITORING SYSTEM
K883817
Boehringer Mannheim Corp.
Chemistry · 92d
Cleared Jul 12, 1988
TRACER(TM) II BLOOD GLUCOSE SYSTEM
K881908
Boehringer Mannheim Corp.
Chemistry · 67d
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 Oct 20, 1987
DIASCAN* BLOOD GLUCOSE SELF-MONITORING TEST STRIPS
K872505
Home Diagnostics, Inc.
Chemistry · 118d
Cleared Aug 31, 1987
BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT
K873117
Biotrol, USA, Inc.
Chemistry · 21d
Cleared May 12, 1987
GLUCOSE ENZYME - COLOR REAGENT SET
K871650
Biochemical Trade, Inc.
Chemistry · 14d
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 Mar 06, 1987
GLUCOSE OXIDASE REAGENT
K870616
Intersect Systems, Inc.
Chemistry · 22d
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