FDA Product Code
FDA Product Code NBW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1345
510(k) Clearances — 511 records · page 5 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K070255 | NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002 | Nova Biomedical Corp. | 2007-06-13 | Traditional | PDF ↗ |
| K070239 | MAXIMED EXICHEK TD-4224 BLOOD GLUCOSE MONITORING SYSTEM | Exir Pharmaceutical Co. | 2007-05-25 | Traditional | PDF ↗ |
| K070585 | ACCU-CHEK PERFORMA SYSTEM | Roche Diagnostics Corp. | 2007-05-25 | Traditional | PDF ↗ |
| K062395 | ACCU-CHEK SMART PIX | Roche Diagnostics Corp. | 2007-05-09 | Traditional | PDF ↗ |
| K070593 | TRACKRECORD DATA MANAGEMENT SOFTWARE | Home Diagnostics, Inc. | 2007-05-07 | Traditional | PDF ↗ |
| K062538 | EASY CHECK BLOOD GLUCOSE MONITORING SYSTEM | Diacare Corp. | 2007-04-30 | Traditional | PDF ↗ |
| K070850 | FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM | Abbott Diabetes Care, Inc. | 2007-04-10 | Special | PDF ↗ |
| K070641 | ADVOCATE DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223 | Taidoc Technology Corporation | 2007-04-09 | Special | PDF ↗ |
| K070472 | CLEVER CHEK TD-4230 BLOOD GLUCOSE MONITORING SYSTEM, RD-4230, SURECHEK BLOOD GLUCOSE MONITORING SYSTEM, SMS-4230 | Taidoc Technology Corporation | 2007-03-15 | Special | PDF ↗ |
| K062567 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM | Bionime Corporation | 2007-02-16 | Traditional | PDF ↗ |
| K070088 | ASSURE 4 BLOOD GLUCOSE MONITORING SYSTEM | Apex BioTechnology Corp. | 2007-02-16 | Special | PDF ↗ |
| K063026 | OK METER BLOOD GLUCOSE MONITORING SYSTEM | Ok Biotech Co., Ltd. | 2007-02-09 | Traditional | PDF ↗ |
| K070017 | PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPS | Polymer Technology Systems, Inc. | 2007-01-31 | Special | PDF ↗ |
| K063409 | LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067 | Agamatrix | 2007-01-12 | Traditional | PDF ↗ |
| K062800 | CLEVER CHEK TD-3213/ CLEVER CHEK TD-3215/ DR. T TD-3216/ CLEVER CHEK TD-3217/ CLEVER CHEK TD-3250 BLOOD GLUCOSE PLUS BLO | Taidoc Technology Corporation | 2007-01-12 | Traditional | PDF ↗ |
| K062555 | EBSENSOR BLOOD GLUCOSE MONITORING SYSTEM, MODEL EB-G | Visgeneer, Inc. | 2006-12-27 | Traditional | PDF ↗ |
| K063068 | FERRARA BLOOD GLUCOSE MONITORING SYSTEM, MODEL 631100 | Arkray USA, Inc. | 2006-12-20 | Traditional | PDF ↗ |
| K062770 | COPILOT HEALTH MANAGEMENT SYSTEM | Abbott Diabetes Care, Inc. | 2006-12-14 | Traditional | PDF ↗ |
| K063212 | CLEVER CHEK TD-4231 AND TD-4223 BLOOD GLUCOSE MONITORING SYSTEM | Taidoc Technology Corporation | 2006-11-22 | Special | PDF ↗ |
| K062347 | ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM | Bayer Healthcare, LLC | 2006-11-22 | Traditional | PDF ↗ |
| K062434 | ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528 | Agamatrix | 2006-11-13 | Special | PDF ↗ |
| K061234 | GLUCOPLUS BLOOD GLUCOSE MONITORING SYSTEM | Glucoplus, Inc. | 2006-10-30 | Traditional | PDF ↗ |
| K062829 | DIACHEX BLOOD GLUCOSE MONITORING SYSTEM | Tyson Bioresearch, Inc. | 2006-10-10 | Special | PDF ↗ |
| K062235 | EASY CHECK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM; CLEVER CHECK TD-4222, TD-4225, TD-4226 BLOOD GLUCOSE MONITORING SYST | Taidoc Technology Corporation | 2006-09-19 | Traditional | PDF ↗ |
| K062058 | ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080 | Bayer Healthcare | 2006-09-11 | Traditional | PDF ↗ |
| K062195 | MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM | Lifescan, Inc. | 2006-08-16 | Special | PDF ↗ |
| K060620 | ACCU-CHEK AVIVA TEST STRIPS | Roche Diagnostics Corp. | 2006-08-11 | Traditional | PDF ↗ |
| K060793 | ELEMENT BLOOD GLUCOSE TEST SYSTEM | Home Diagnostics, Inc. | 2006-07-25 | Special | PDF ↗ |
| K060467 | PRODIGY BLOOD GLUCOSE TEST SYSTEM | Diagnostic Devices, Inc. | 2006-07-13 | Traditional | PDF ↗ |
| K061181 | ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4207 | Taidoc Technology Corporation | 2006-07-06 | Traditional | PDF ↗ |
| K053593 | PRODIGY | Diagnostic Devices, Inc. | 2006-07-06 | Traditional | PDF ↗ |
| K052818 | EZ SMART-168 GLUCOSE MONITORING SYSTEM | Tyson Bioresearch, Inc. | 2006-06-16 | Traditional | PDF ↗ |
| K061328 | THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM) | E-San Limited | 2006-06-13 | Traditional | PDF ↗ |
| K052469 | GLUCOPACK | Healthpia America Corp. | 2006-06-05 | Traditional | PDF ↗ |
| K061118 | ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM | Lifescan, Inc. | 2006-05-19 | Special | PDF ↗ |
| K051651 | G4, MODEL IGM-0004 | U. S. Diagnostics, Inc. | 2006-04-14 | Traditional | PDF ↗ |
| K060470 | ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; ASCENSIA MICROFILL REAGENT STRIP, MODEL 7080 | Bayer Healthcare | 2006-04-12 | Traditional | PDF ↗ |
| K051839 | FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 11001 | Abbott Diabetes Care, Inc. | 2006-03-09 | Traditional | PDF ↗ |
| K053312 | EASYMATE BLOOD GLUCOSE MONITORING SYSTEM | Bioptik Technology, Inc. | 2006-03-01 | Traditional | PDF ↗ |
| K053635 | MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM | Bionime Corporation | 2006-02-21 | Traditional | PDF ↗ |
| K052762 | LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067 | Agamatrix, Inc. | 2006-01-23 | Traditional | PDF ↗ |
| K053529 | ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM | Lifescan, Inc. | 2006-01-17 | Special | PDF ↗ |
| K052208 | GLUCOSE PILOT | Tianjin New Bay Bioresearch Co., Ltd. | 2005-12-09 | Traditional | PDF ↗ |
| K052343 | E-SAN BLUETOOTH CRADLE | E-San Limited | 2005-12-07 | Traditional | PDF ↗ |
| K052108 | SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100 | Sein Electronics Co., Ltd. | 2005-12-07 | Abbreviated | PDF ↗ |
| K050985 | GLUCODR SUPERSENSOR SYSTEM | All Medicus Co., Ltd. | 2005-10-07 | Traditional | PDF ↗ |
| K051514 | ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002 | Hypoguard USA, Inc. | 2005-10-04 | Traditional | PDF ↗ |
| K051802 | FREESTYLE CONNECT BLOOD GLUCOSE MONITORING SYSTEM | Abbott Diabetes Care, Inc. | 2005-08-09 | Special | PDF ↗ |
| K051936 | CLEVER CHECK TD-3215/DR. T TD-3216 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEMS | Taidoc Technology Corporation | 2005-08-08 | Special | PDF ↗ |
| K051854 | CLEVER CHEK TD-4225, MODEL TD-4225 | Taidoc Technology Corporation | 2005-08-05 | Special | PDF ↗ |
| K050224 | 3TEST GLUCOSE MONITORING SYSTEM | Neuero Engineering, Inc. | 2005-07-13 | Traditional | PDF ↗ |
| K051147 | SIDEKICK BLOOD GLUCOSE TEST SYSTEM | Home Diagnostics, Inc. | 2005-07-12 | Special | PDF ↗ |
| K050500 | FREESTYLE 600 BLOOD GLUCOSE MONITORING SYSTEM | Abbott Diabetes Care, Inc. | 2005-06-27 | Traditional | PDF ↗ |
| K043340 | EZ SMART | Vip Diagnostics, LLC | 2005-06-02 | Traditional | PDF ↗ |
| K051213 | PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS | Abbott Laboratories, Inc. | 2005-05-27 | Special | PDF ↗ |
| K043543 | BLOOD GLUCOSE MONITORING SYSTEM | American Healthcare, Inc. | 2005-04-08 | Traditional | PDF ↗ |
| K042795 | CLEVER CHEK TD-3213 | Taidoc Technology Corporation | 2005-03-07 | Traditional | PDF ↗ |
| K042678 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM | Bionime Corporation | 2005-01-03 | Traditional | PDF ↗ |
| K043158 | ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM | Bayer Healthcare, LLC | 2004-12-22 | Traditional | PDF ↗ |
| K043311 | ASCENSIA ELITE DIABETES CARE SYSTEM | Bayer Healthcare, LLC | 2004-12-22 | Special | PDF ↗ |
| K042005 | ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222 | Taidoc Technology Corporation | 2004-08-27 | Special | PDF ↗ |
| K040848 | EZ SMART | Vip International Wholesalers, Corp. | 2004-08-11 | Traditional | PDF ↗ |
| K041750 | PTS PANELS CHOL+GLU TEST PANEL | Polymer Technology Systems, Inc. | 2004-07-23 | Special | PDF ↗ |
| K040678 | EUSURE BLOOD GLUCOSE MONITORING SYSTEM | Eumed Biotechnology Co., Ltd. | 2004-07-14 | Traditional | PDF ↗ |
| K041107 | TAIDOC CHECK | Taidoc Technology Corporation | 2004-06-18 | Traditional | PDF ↗ |
| K040603 | PARADIGM LINK BLOOD GLUCOSE METER | Becton, Dickinson & CO | 2004-05-19 | Traditional | PDF ↗ |
| K040814 | MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM | Abbott Laboratories | 2004-04-15 | Special | PDF ↗ |
| K040628 | PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM | Abbott Laboratories | 2004-03-25 | Special | PDF ↗ |
| K040670 | MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL | Home Diagnostics, Inc. | 2004-03-25 | Special | PDF ↗ |
| K032657 | TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND GLUCOSE CONTROL SOLUTIONS (LOW AND HIGH) | Home Diagnostics, Inc. | 2004-03-24 | Traditional | PDF ↗ |
| K033845 | PRECISION XCEED DIABETES MONITORING SYSTEM | Abbott Laboratories | 2004-01-08 | Special | PDF ↗ |
| K031260 | FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005 | Abbott Diabetes Care, Inc. | 2003-12-19 | Traditional | PDF ↗ |
| K032029 | BTG SMARTEST GLUCOSE TEST SYSTEM | Bt Medical | 2003-12-18 | Traditional | PDF ↗ |
| K032985 | GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM | Hmd Biomedical, Inc. | 2003-10-21 | Special | PDF ↗ |
| K031501 | EASYGLUCO, MODEL IGM0002 | American Healthcare, Inc. | 2003-10-16 | Traditional | PDF ↗ |
| K032552 | ACCU-CHEK ADVANTAGE SYSTEM | Roche Diagnostics Corp. | 2003-09-12 | Special | PDF ↗ |
| K023279 | GLUCOLEADER VALUE | Hmd Biomedical, Inc. | 2003-08-04 | Traditional | PDF ↗ |
| K030703 | TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS | Home Diagnostics, Inc. | 2003-07-11 | Traditional | PDF ↗ |
| K031843 | MODIFICATION TO EVENCARE BLOOD GLUCOSE MONITORING SYSTEM | Medline Industries, Inc. | 2003-07-03 | Special | PDF ↗ |
| K023256 | PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLO | Abbott Laboratories | 2003-04-23 | Traditional | PDF ↗ |
| K024194 | ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS | Lifescan, Inc. | 2003-02-07 | Traditional | PDF ↗ |
| K024234 | ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL | Bayer Corp. | 2003-01-23 | Traditional | PDF ↗ |
| K023832 | SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM | Lifescan, Inc. | 2002-12-13 | Special | PDF ↗ |
| K023219 | BECTON DICKINSON DIABETES SOFTWARE | Becton, Dickinson & CO | 2002-12-06 | Traditional | PDF ↗ |
| K023584 | ASCENSIA DEX 2 DIABETES CARE SYSTEM | Bayer Corp. | 2002-11-20 | Special | PDF ↗ |
| K022545 | GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020 | Hypoguard USA, Inc. | 2002-10-11 | Traditional | PDF ↗ |
| K022581 | BECTON DICKINSON LOGIC BLOOD GLUCOSE MONITORING SYSTEM | Becton, Dickinson & CO | 2002-10-09 | Traditional | PDF ↗ |
| K022724 | SURESTEP BLOOD GLUCOSE MONITORING SYSTEM | Lifescan, Inc. | 2002-09-12 | Special | PDF ↗ |
| K022182 | MEDISENSE PRECISION EASYBLOOD GLUCOSE MONITORING SYSTEM, MEDISENSE OPTIUM EASYBLOOD GLUCOSE MONITORING SYSTEM | Abbott Laboratories | 2002-09-09 | Traditional | PDF ↗ |
| K021819 | ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM | Lifescan, Inc. | 2002-08-23 | Traditional | PDF ↗ |
| K022171 | ACCU-CHEK COMPACT SYSTEM | Roche Diagnostics Corp. | 2002-07-23 | Special | PDF ↗ |
| K021827 | MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM | Roche Diagnostics Corp. | 2002-07-03 | Special | PDF ↗ |
| K021513 | ACCU-CHEK ADVANTAGE MODULE | Roche Diagnostics Corp. | 2002-06-11 | Special | PDF ↗ |
| K020866 | FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM | Abbott Diabetes Care, Inc. | 2002-06-11 | Special | PDF ↗ |
| K021448 | MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM | Roche Diagnostics Corp. | 2002-06-03 | Special | PDF ↗ |
| K020210 | GLUCOMETER DEX BLOOD GLUCOSE SYSTEM (MODIFIED) | Bayer Group Diagnostics | 2002-04-30 | Traditional | PDF ↗ |
| K020208 | GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED) | Bayer Group Diagnostics | 2002-04-29 | Traditional | PDF ↗ |
| K012975 | SOF-TACT DIABETES MANAGEMENT SYSYEM; SOF-TACT BLOOD GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS | Abbott Laboratories | 2002-02-28 | Traditional | PDF ↗ |
| K014167 | LIBERTY BLOOD GLUCOSE MONITORING SYSTEM | Polymedica Pharmaceuticals, U.S.A., Inc.] | 2002-02-19 | Traditional | PDF ↗ |
| K014099 | BIOSCANNER PLUS | Polymer Technology Systems, Inc. | 2001-12-21 | Special | PDF ↗ |
Product code NBW · Class II · Clinical Chemistry. Data: openFDA.