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)
Top companies in CGA
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 30, 2004 | K033055 | GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS Diamond Diagnostics, Inc. | CGA |
| Dec 4, 2003 | K024014 | RANDOX RX DAYTONA Randox Laboratories, Ltd., GB | CGA |
| Aug 5, 2003 | K031472 | ONE TOUCH BASIC/PROFILE/ONE TOUCH II TEST STRIPS Lifescan, Inc. | CGA |
| May 22, 2003 | K031388 | MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM Hypoguard USA, Inc. | CGA |
| Mar 28, 2003 | K024347 | EXPRESS BLOOD GLUCOSE MONITORING SYSTEM Hypoguard USA, Inc. | CGA |
| Mar 3, 2003 | K024062 | ASCENSIA BREEZE BLOOD GLUCOSE METER Bayer Corp. | CGA |
| Oct 24, 2002 | K023194 | SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM Lifescan, Inc. | CGA |
| Oct 9, 2002 | K022580 | BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM Becton, Dickinson & CO | CGA |
| Sep 10, 2002 | K022158 | IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT) Instrumentation Laboratory CO | CGA |
| Aug 30, 2002 | K021781 | EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. PRESTIGE LX AND IQ BLOOD GLUCOSE SYSTEMS Chay Medical, LLC | CGA |
| Jun 28, 2002 | K021943 | ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc. | CGA |
| Apr 3, 2002 | K020935 | HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706 Hemocue, Inc. | CGA |
| Mar 21, 2002 | K014139 | DIABETES ASSISTANT SOFTWARE Roche Diagnostics Corp. | CGA |
| Feb 15, 2002 | K013342 | EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. Chay Medical, LLC | CGA |
| Feb 12, 2002 | K020232 | HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM Hypoguard USA, Inc. | CGA |
| Dec 21, 2001 | K011953 | WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER LAB. GILICEMIA ENZCA Wiener Laboratories Saic, AR | CGA |
| Nov 30, 2001 | K011479 | ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM Inverness Medical Innovations, Inc. | CGA |
| Nov 20, 2001 | K013068 | BIOSCANNER 2000 Polymer Technology Systems, Inc. | CGA |
| May 18, 2001 | K011233 | MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100 Apex BioTechnology Corp. | CGA |
| May 7, 2001 | K010605 | ATLAST DATA MANAGEMENT SOFTWARE (DMS) Amira Medical, Inc. | CGA |
| May 7, 2001 | K010520 | GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS Instrumentation Laboratory CO | CGA |
| Mar 15, 2001 | K003346 | RANDOX GLUCOSE (GOD/PAP) Randox Laboratories, Ltd., GB | CGA |
| Feb 1, 2001 | K002688 | PERSONAL GLUCOSE CONTROL CHARTING SYSTEM Lxn Corp. | CGA |
| Jan 22, 2001 | K002624 | GLUCOSMART BLOOD GLUCOSE MONITORING SYSTEM Apex BioTechnology Corp. | CGA |
| Jan 22, 2001 | K002621 | GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM Apex BioTechnology Corp. | CGA |
| Dec 22, 2000 | K003257 | EHC400 DESKTOP PATIENT STATION; ECH600 CARE PROVIDER STATION Cybercare Technologies, Inc. | CGA |
| Dec 18, 2000 | K001441 | SATURN BLOOD GLUCOSE MONITORING TEST STRIP Lifescan, Inc. | CGA |
| Oct 5, 2000 | K001387 | I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300 I-Stat Corp. | CGA |
| Sep 5, 2000 | K001907 | CAMIT DIABETES MANAGEMENT SOFTWARE Roche Diagnostics Corp. | CGA |
| Aug 7, 2000 | K002134 | ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM Selfcare, Inc. | CGA |
| Jul 26, 2000 | K001092 | GENERIC BLOOD GLUCOSE TEST STRIP Inbios Intl., Inc. | CGA |
| Jun 2, 2000 | K001427 | MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM Selfcare, Inc. | CGA |
| Mar 17, 2000 | K000583 | FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM Selfcare, Inc. | CGA |
| Feb 23, 2000 | K000365 | ACCU-CHEK ADVANTAGE METER Roche Diagnostics Corp. | CGA |
| Dec 16, 1999 | K993837 | AVL OPTI CRITICAL CARE ANALYZER Avl Scientific Corp. | CGA |
| Nov 23, 1999 | K993128 | HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER] Health Hero Network, Inc. | CGA |
| Nov 12, 1999 | K993632 | FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM Selfcare, Inc. | CGA |
| Sep 24, 1999 | K992988 | PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM Home Diagnostics, Inc. | CGA |
| Sep 17, 1999 | K991480 | EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP Selfcare, Inc. | CGA |
| Sep 8, 1999 | K991754 | GO GLUCOSE MONITORING SYSTEM Lxn Corp. | CGA |
| Aug 2, 1999 | K990942 | DUET II GLUCOSE CONTROL MONITORING SYSTEM Lxn Corp. | CGA |
| Jul 9, 1999 | K990649 | GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS Bayer Corp. | CGA |
| Jul 9, 1999 | K983504 | PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISION BLOOD GLUCOSE TEST STRIPS, PRECISION XTRA B-KETONE TEST ST Medisense, Inc. | CGA |
| Jun 30, 1999 | K991242 | GLUCOMETER ELITE TEST STRIPS Bayer Corp. | CGA |
| Jun 22, 1999 | K983344 | DADE BEHRING QUIKLYTE METABOLYTE CARTRIDGE, MODEL DIMENSION(R) XL OR RXL Dade Behring, Inc. | CGA |
| May 21, 1999 | K984261 | SURESTEP BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc. | CGA |
| Apr 29, 1999 | K984527 | IN TOUCH DIABETES MANAGEMENT SOFTWARE Lifescan, Inc. | CGA |
| Apr 20, 1999 | K990939 | FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM Selfcare, Inc. | CGA |
| Mar 18, 1999 | K984006 | GLUCOMETER ELITE XL BLOOD GLUCOSE METER Bayer Corp. | CGA |
| Dec 10, 1998 | K982076 | AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM Amira Medical, Inc. | CGA |
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