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
73–96 of 401
Cleared Jan 26, 1998
ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
K974451
Lifescan, Inc.
Chemistry · 62d
Cleared Dec 16, 1997
ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM DATA DOCK
K972473
Lifescan, Inc.
Chemistry · 168d
Cleared May 12, 1997
SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEM
K970556
Lifescan, Inc.
Chemistry · 88d
Cleared Apr 21, 1997
LIQUID GLUCOSE (OXIDASE) REAGENT SET
K970781
Pointe Scientific, Inc.,
Chemistry · 48d
Cleared Feb 10, 1997
GLUCOMETER ELITE BLOOD GLUCOSE METER
K964630
Bayer Corp.
Chemistry · 83d
Cleared Jan 21, 1997
GLUCOMETER DEX DIABETES CARE SYSTEM
K963500
Bayer Corp.
Chemistry · 140d
Cleared Jan 17, 1997
SIGMA DIAGNOSTICS GLUCOSE REAGENT
K963535
Sigma Diagnostics, Inc.
Chemistry · 135d
Cleared Apr 17, 1996
ACCU-CHEK INSTANT PLUS G-C/DM BLOOD GLUCOSE MONITORING SYSTEM
K944459
Boehringer Mannheim Corp.
Chemistry · 583d
Cleared Nov 21, 1995
ACCU-CHEK ALPHA MONITOR & ACCU-CHEK GLUCOSE TEST STRIPS
K952875
Boehringer Mannheim Corp.
Chemistry · 155d
Cleared Oct 17, 1995
EML105 ELECTROLYTE METABOLITE ANALYZER
K952621
Radiometer America, Inc.
Chemistry · 131d
Cleared Oct 05, 1995
WAKO AUTOKIT GLUCOSE
K950172
Wako Chemicals USA, Inc.
Chemistry · 261d
Cleared Jul 14, 1995
GLUCOMETER ELITE M BLOOD GLUCOSE METER
K951537
Bayer Corp.
Chemistry · 102d
Cleared Jul 03, 1995
ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
K950816
Lifescan, Inc.
Chemistry · 131d
Cleared Jun 01, 1995
ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEM
K950727
Lifescan, Inc.
Chemistry · 105d
Cleared Mar 24, 1995
LIFESCAN SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
K942455
Lifescan, Inc.
Chemistry · 305d
Cleared Nov 04, 1994
SIGMA GLUCOSE REAGENT
K933694
Sigma Chemical Co.
Chemistry · 463d
Cleared Oct 20, 1994
DMA GLUCOSE (OXIDASE) PROCEDURE
K943241
Data Medical Associates, Inc.
Chemistry · 106d
Cleared May 10, 1994
GLUCOFILM TEST STRIPS
K936212
Heraeus Kulzer, Inc.
Chemistry · 133d
Cleared Dec 07, 1993
GLUCOMETER QA BLOOD GLUCOSE METER MODIFICATION
K934898
Heraeus Kulzer, Inc.
Chemistry · 55d
Cleared Nov 10, 1993
GLUCOSTIX REAGENT STRIPS
K926362
Heraeus Kulzer, Inc.
Chemistry · 324d
Cleared Sep 08, 1993
GLUCOFILM TEST STRIPS
K926360
Heraeus Kulzer, Inc.
Chemistry · 261d
Cleared Sep 08, 1993
ACCU-CHEK ADVANTAGE BLOOD GLUCOSE SYSTEM
K930979
Boehringer Mannheim Corp.
Chemistry · 195d
Cleared Jun 25, 1993
GLUCOMETER M+ BLOOD GLUCOSE METER
K931310
Heraeus Kulzer, Inc.
Chemistry · 102d
Cleared Apr 20, 1993
HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807
K925551
Hichem Diagnostics
Chemistry · 168d