ClearanceBrief
Panels › Clinical Chemistry › Product code CGA · Class 2

Glucose Oxidase, Glucose

Regulation 862.1345

1510(k)s in 12 months (401 all time)
0recalls in 12 months (89 all time)
79recalls that name a 510(k)
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Top companies in CGA

Company510(k)sRecalls
Lifescan, Inc.215
Roche Diagnostics Corp.320
Boehringer Mannheim Corp.170
Apex BioTechnology Corp.140
Abbott Point of Care, Inc.66
Miles Laboratories, Inc.120
Nova Biomedical Corp.75
Instrumentation Laboratory CO92
Medisense, Inc.110
Heraeus Kulzer, Inc.100
Decided510(k)Device and applicantCode
Dec 8, 1998K982303PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST ST
Medisense, Inc.
CGA
Jul 30, 1998K980573SENSOREX BLOOD GLUCOSE MONITORING SYSTEM
Chronimed, Inc.
CGA
May 7, 1998K981183CARESIDE GLUCOSE
Exigent Diagnostics, Inc.
CGA
Jan 26, 1998K974451ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
Lifescan, Inc.
CGA
Jan 22, 1998K972669MTM BIOSCANNER 1000 TEST SYSTEM CONSISTING OF MTM BIOSCANNER 1000 METER, MTM BIOSCANNER G TEST STRIP, NORMAN GLUCOSE CON
Polymer Technology Systems, Inc.
CGA
Jan 2, 1998K971653GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM
Clinical Diagnostics, Inc.
CGA
Dec 16, 1997K972473ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM DATA DOCK
Lifescan, Inc.
CGA
Oct 31, 1997K973140DUET GLUCOSE CONTROL MONITORING SYSTEM
Lxn Corp.
CGA
Sep 17, 1997K971145GLUCOSITE TEST SYSTEM
Gds Technology, LLC
CGA
Sep 9, 1997K972733AVL OMNI ANALYZER
Avl Scientific Corp.
CGA
Aug 8, 1997K971812PRECISION QID BLOOD GLUCOSE TEST STRIP, PRECISION G BLOOD GLUCOSE TEST STRIP
Medisense, Inc.
CGA
Jun 20, 1997K970707ELECT II BLOOD GLUCOSE MONITORING SYSTEM
Selfcare, Inc.
CGA
May 12, 1997K970556SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEM
Lifescan, Inc.
CGA
Apr 21, 1997K970781LIQUID GLUCOSE (OXIDASE) REAGENT SET
Pointe Scientific, Inc.,
CGA
Feb 20, 1997K963676PRECISION G BLOOD GLUCOSE TESTING SYSTEM
Medisense, Inc.
CGA
Feb 20, 1997K963544SUPREME II METER
Chronimed, Inc.
CGA
Feb 10, 1997K964630GLUCOMETER ELITE BLOOD GLUCOSE METER
Bayer Corp.
CGA
Jan 21, 1997K963500GLUCOMETER DEX DIABETES CARE SYSTEM
Bayer Corp.
CGA
Jan 17, 1997K963535SIGMA DIAGNOSTICS GLUCOSE REAGENT
Sigma Diagnostics, Inc.
CGA
Nov 7, 1996K960855PRESTIGE BLOOD GLUCOSE MONITORING SYSTEM,METER,TEST STRIPS & PRESTIGE HIGH AND LOW GLUCOSE CONTROL
Home Diagnostics, Inc.
CGA
Sep 24, 1996K960337AMD HOME HEALTH MONITORING SYSTEM
Advanced Medical Devices, Inc.
CGA
Sep 5, 1996K961985ELECT BLOOD GLUCOSE MONITORIG SYSTEM
Selfcare, Inc.
CGA
Aug 16, 1996K955107SAFESTRIP
Firehouse Medical, Inc.
CGA
Jul 26, 1996K962295PRECISION QID BLOOD GLUCOSE TEST STRIP
Medisense, Inc.
CGA
Jul 23, 1996K943503CHEMCARD GLUCOSE TEST
Chem-Elec, Inc.
CGA
Jun 28, 1996K960053SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH SYSTEM
Selfcare, Inc.
CGA
Jun 28, 1996K960034LXN BLOOD GLUCOSE TEST SYSTEM
Lxn Corp.
CGA
Jun 21, 1996K961337EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM
Medisense, Inc.
CGA
May 17, 1996K955286EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU)
Johnson & Johnson Clinical Diagnostics, Inc.
CGA
Apr 17, 1996K944459ACCU-CHEK INSTANT PLUS G-C/DM BLOOD GLUCOSE MONITORING SYSTEM
Boehringer Mannheim Corp.
CGA
Feb 22, 1996K951457GLUCOCHEK POCKETLAB
Clinical Diagnostics, Inc.
CGA
Nov 21, 1995K952875ACCU-CHEK ALPHA MONITOR & ACCU-CHEK GLUCOSE TEST STRIPS
Boehringer Mannheim Corp.
CGA
Nov 8, 1995K950628FIRST CHOICE TEST STRIP
Polymer Technology Intl.
CGA
Nov 8, 1995K946166FIRST CHOICE(TM) TEST STRIP
Polymer Technology Intl.
CGA
Oct 17, 1995K952621EML105 ELECTROLYTE METABOLITE ANALYZER
Radiometer America, Inc.
CGA
Oct 5, 1995K950172WAKO AUTOKIT GLUCOSE
Wako Chemicals USA, Inc.
CGA
Jul 14, 1995K951537GLUCOMETER ELITE M BLOOD GLUCOSE METER
Bayer Corp.
CGA
Jul 3, 1995K950816ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
Lifescan, Inc.
CGA
Jun 14, 1995K952279PRECISION LINK BLOOD GLUCOSE DATA MANAGEMENT SYSTEM
Medisense, Inc.
CGA
Jun 1, 1995K950727ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEM
Lifescan, Inc.
CGA
Mar 24, 1995K942455LIFESCAN SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
Lifescan, Inc.
CGA
Mar 23, 1995K945887PRECISION Q I D BLOOD GLUCOSE TEST STRIPS
Medisense, Inc.
CGA
Mar 23, 1995K944195QUICKPRO BLOOD GLUCOSE TESTING SYSTEM
Medisense, Inc.
CGA
Jan 17, 1995K943432HEMOCUE B-GLUCOSE SYSTEM
Hemocue, Inc.
CGA
Jan 17, 1995K940215GLUCOCHEK
Clinical Diagnostics, Inc.
CGA
Nov 4, 1994K933694SIGMA GLUCOSE REAGENT
Sigma Chemical Co.
CGA
Oct 20, 1994K943241DMA GLUCOSE (OXIDASE) PROCEDURE
Data Medical Associates, Inc.
CGA
May 10, 1994K936212GLUCOFILM TEST STRIPS
Heraeus Kulzer, Inc.
CGA
Jan 11, 1994K934892RELIEF PLUS ONE REAGENT STRIP MODIFICATION
Diagnostic Solutions, Inc.
CGA
Dec 7, 1993K934898GLUCOMETER QA BLOOD GLUCOSE METER MODIFICATION
Heraeus Kulzer, Inc.
CGA

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