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 3 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K130094 | FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM | Abbott Diabetes Care | 2013-06-27 | Traditional | PDF ↗ |
| K130295 | LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM. | Infopia Co, Ltd. | 2013-06-21 | Special | PDF ↗ |
| K123007 | VERI-Q MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM, VERI-Q PLUS MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM | Mico Biomed Co., Ltd. | 2013-06-19 | Traditional | PDF ↗ |
| K123016 | VERI-Q SELF-TESTING AND VERI-Q PLUS MGD-2001 BLOOD GLUCOSE MONITORING SYSTEMS | Mico Biomed Co., Ltd. | 2013-06-18 | Traditional | PDF ↗ |
| K123087 | TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE MONITORING SYSTEM | Tyson Bioresearch, Inc. | 2013-06-18 | Special | PDF ↗ |
| K124040 | FORACARE GD20 BLOOD GLUCOSE MONITORING SYSTEM | Taidoc Technology Corporation | 2013-05-16 | Traditional | PDF ↗ |
| K122525 | SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE MULTI BLOOD GLUCOSE MONITORING SYSTEM | Biotest Medical Corp. | 2013-05-02 | Special | PDF ↗ |
| K130886 | GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATION | Glooko, Inc. | 2013-04-25 | Special | PDF ↗ |
| K120989 | TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM | Nipro Diagnostics, Inc. | 2013-04-24 | Traditional | PDF ↗ |
| K130535 | IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION | Agamatrix, Inc. | 2013-04-17 | Special | PDF ↗ |
| K123935 | IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM | Andon Medical Co., Ltd. | 2013-04-12 | Traditional | PDF ↗ |
| K123089 | FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001 | Abbott Laboratories | 2013-04-05 | Traditional | PDF ↗ |
| K122307 | DIAVUE PRUDENTIAL BLOOD GLUCOSE MONITORING SYSTEM | Biocare Corporation | 2013-04-05 | Traditional | PDF ↗ |
| K130138 | SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM | Roche Diagnostics Corp. | 2013-03-15 | Special | PDF ↗ |
| K123136 | GENESIS HEALTH RECORD SYSTEM, (GHRS) | Genesis Health Technologies | 2013-03-07 | Traditional | PDF ↗ |
| K113614 | ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM | Roche Diagnostics | 2013-02-12 | Traditional | PDF ↗ |
| K102751 | LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM | Ceragem Medisys, Inc. | 2013-02-11 | Traditional | PDF ↗ |
| K120558 | ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION | Lifescan, Inc. | 2013-02-07 | Traditional | PDF ↗ |
| K120708 | ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEM | Cilag GmbH International | 2013-02-07 | Traditional | PDF ↗ |
| K123008 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORIN | Bionime Corporation | 2013-01-25 | Special | PDF ↗ |
| K122142 | GLOOKO LOGBOOK CHARTS | Glooko, Inc. | 2012-12-21 | Traditional | PDF ↗ |
| K123010 | ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM | ACON Laboratories, Inc. | 2012-12-14 | Traditional | PDF ↗ |
| K120866 | DA01 BLOOD GLUCOSE MONITORING SYSTEM | Delbio Incorporation | 2012-12-11 | Traditional | PDF ↗ |
| K120813 | BLOOD GLUCOSE MONITORING SYSTEM | Andon Medical Co., Ltd. | 2012-12-07 | Traditional | PDF ↗ |
| K103542 | GENSTRIP TEST STRIP MODEL 100-201 | Shasta Technologies, LLC | 2012-11-30 | Traditional | PDF ↗ |
| K121679 | ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM | Roche Diagnostics | 2012-10-11 | Traditional | PDF ↗ |
| K120064 | TEST, BLOOD GLUCOSE SYSTEM | Hmd Biomedical, Inc. | 2012-09-05 | Traditional | PDF ↗ |
| K112916 | TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEM | Tyson Bioresearch, Inc. | 2012-08-21 | Traditional | PDF ↗ |
| K120423 | BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650 | Bionime Corporation | 2012-08-03 | Traditional | PDF ↗ |
| K113077 | BIOLAND G-423 GLOOD GLUCOSE MONITORING SYSTEM | Taidoc Technology Corporation | 2012-08-03 | Traditional | PDF ↗ |
| K113192 | HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM | Infopia Co, Ltd. | 2012-07-13 | Traditional | PDF ↗ |
| K121133 | CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM | I-Sens, Inc. | 2012-07-10 | Special | PDF ↗ |
| K120649 | AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEM | Apex BioTechnology Corp. | 2012-07-06 | Special | PDF ↗ |
| K121087 | CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM | Bayer Healthcare | 2012-06-28 | Special | PDF ↗ |
| K110074 | HL 568 SELF MONITORING BLOOD GLUCOSE SYSTEM, HL 568BA SELF-MONIROTING BLOOD GLUCOSE SYSTEM | Health & Life Co., Ltd. | 2012-05-25 | Traditional | PDF ↗ |
| K120183 | ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM | Broadmaster Biotech Corperation | 2012-05-11 | Special | PDF ↗ |
| K120351 | CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CA | I-Sens, Inc. | 2012-05-03 | Special | PDF ↗ |
| K120568 | FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM | Abbott Diabetes Care, Inc. | 2012-03-29 | Special | PDF ↗ |
| K110737 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 | Bionime Corporation | 2012-03-29 | Traditional | PDF ↗ |
| K103329 | DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION | Delbio Incorporation | 2012-03-13 | Traditional | PDF ↗ |
| K112638 | NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS | Nova Biomedical Corporation | 2012-03-09 | Traditional | PDF ↗ |
| K111456 | MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM | Tianjin Empecs Medical Device Co., Ltd. | 2012-02-28 | Traditional | PDF ↗ |
| K103044 | AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION | Bestgen Biotech Corp. | 2012-02-10 | Traditional | PDF ↗ |
| K113343 | DIACHECK SMART/SUPERIOR BLOOD GLUCOSE MONITORING SYSTEM | Delbio Incorporation | 2012-02-08 | Special | PDF ↗ |
| K111890 | FORA DIAMOND PRIMA BLOOD GLUCOSE MONITORING SYSTEM, FORA DIAMOND MINI BLOOD GLUCOSE MONITORING SYSTEM | Taidoc Technology Corporation | 2012-02-06 | Traditional | PDF ↗ |
| K102383 | MICRODOT & MICRODOT XTRA | Cambridge Sensors Limited | 2012-01-27 | Traditional | PDF ↗ |
| K110017 | AG-608N BLOOD GLUCOSE MONITORING SYSTEM | Andon Medical Co., Ltd. | 2012-01-18 | Traditional | PDF ↗ |
| K113098 | AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS III | Apex BioTechnology Corp. | 2012-01-17 | Traditional | PDF ↗ |
| K100437 | AP-1000 BLOOD GLUCOSE MONITORING SYSTEM, MODEL AP-1000, MAJOR GLUCOSE CONTROL SOLUTION | Bestgen Biotech Corp. | 2012-01-12 | Traditional | PDF ↗ |
| K113137 | GLUCOSE TEST SYSTEM | Roche Diagnostics | 2012-01-06 | Special | PDF ↗ |
| K101926 | FORA D40 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM | Taidoc Technology Corporation | 2011-12-20 | Traditional | PDF ↗ |
| K112275 | FORA PREMIUM V10 BLOOD GLUCOSE MONITORING SYSTEM | Taidoc Technology Corporation | 2011-12-15 | Special | PDF ↗ |
| K103544 | IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D | Agamatrix, Inc. | 2011-12-07 | Traditional | PDF ↗ |
| K112963 | TD-4257 BLOOD GLUCOSE MONITORING SYSTEMS,TD 4257 MULTI BLOOD GLUCOSE MONITORING SYSTEMS | Taidoc Technology Corporation | 2011-11-22 | Traditional | PDF ↗ |
| K111932 | IGLUCOSE SYSTEM | Positiveid Corporation | 2011-11-10 | Traditional | PDF ↗ |
| K111509 | SWEETSPOT DIABETES DATA MANAGEMENT SERVICE | Sweetspot Diabetes Care, Inc. | 2011-11-09 | Traditional | PDF ↗ |
| K103021 | ELEMENT PLUS BLOOD GLUCOSE MONITORING SYSTEM | Infopia Co, Ltd. | 2011-11-04 | Special | PDF ↗ |
| K103115 | PRODIGY DIABETES MANAGEMENT SOFTWARE | Prodigy Diabetes Care, LLC | 2011-10-12 | Traditional | PDF ↗ |
| K102063 | HEALTH-E-CONNECT SYSTEM | Alr Technologies | 2011-10-11 | Traditional | PDF ↗ |
| K112738 | ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE | Andon Medical Co., Ltd. | 2011-09-30 | Special | PDF ↗ |
| K103396 | COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION | I-Sens, Inc. | 2011-09-27 | Special | PDF ↗ |
| K110435 | EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM | U. S. Diagnostics, Inc. | 2011-09-21 | Special | PDF ↗ |
| K100806 | DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM | Delbio Incorporation | 2011-09-16 | Traditional | PDF ↗ |
| K102816 | GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS | Apex BioTechnology Corp. | 2011-09-15 | Traditional | PDF ↗ |
| K101631 | FORA GD20 BLOOD GLUCOSE MONITORING SYSTEM, U-RUGHT TD-4252D BLOOD GLUCOSE MONITORING SYSTEM | Taidoc Technology Corporation | 2011-09-02 | Traditional | PDF ↗ |
| K101635 | TD-4239 BLOOD GLUCOSE MONITORING SYSTEM AND TD-4239 MULTI BLOOD GLUCOSE MONITORING SYSTEM | Taidoc Technology Corporation | 2011-08-31 | Traditional | PDF ↗ |
| K101543 | TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200 | Tyson Bioresearch, Inc. | 2011-08-30 | Special | PDF ↗ |
| K102678 | ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI BLOOD GLUCOSE MONITORING SYSTEMS | Andon Medical Co., Ltd. | 2011-08-26 | Traditional | PDF ↗ |
| K101307 | BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951 | Andon Medical Co., Ltd. | 2011-08-09 | Traditional | PDF ↗ |
| K110571 | TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USE | Telcare, Inc. | 2011-07-28 | Traditional | PDF ↗ |
| K093755 | AG-695 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM/AG-696 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM | Andon Medical Co., Ltd. | 2011-07-15 | Traditional | PDF ↗ |
| K111029 | FORA POCT MANAGMENT SYSTEM | Taidoc Technology Corporation | 2011-07-01 | Traditional | PDF ↗ |
| K101509 | U-RIGHT TD-4279 BLOOD GLUCOSE MONITORING SYSTEM, FORA GD40/TD-4272 BLOOD GLUCOSE MONITORING SYSTEM | Taidoc Technology Corporation | 2011-06-27 | Traditional | PDF ↗ |
| K102345 | EASYMAX T1 SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS10042 | Eps Bio Technology Corp. | 2011-06-21 | Special | PDF ↗ |
| K102049 | CLEVER CHOICE VOICE+ BLOOD GLUCOSE MONITORING SYSTEM | Taidoc Technology Corporation | 2011-05-27 | Special | PDF ↗ |
| K110709 | ARK CARE DIABETES MANAGMENT SYSTEM | Arkray Factory USA, Inc. | 2011-05-19 | Traditional | PDF ↗ |
| K110948 | HEALTH CARE SYSTEM SOFTWARE | Taidoc Technology Corporation | 2011-05-13 | Special | PDF ↗ |
| K102481 | AUTOSURE VOICE 3 BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIP | Apex BioTechnology Corp. | 2011-04-28 | Special | PDF ↗ |
| K093745 | ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM | Lifescan, Inc. | 2011-02-11 | Traditional | PDF ↗ |
| K101371 | ON CALL PLUS DIABETES MONITORING SOFTWARE | ACON Laboratories, Inc. | 2011-01-07 | Traditional | PDF ↗ |
| K100937 | PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE | I-Sens, Inc. | 2010-12-21 | Traditional | PDF ↗ |
| K101597 | WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4 | Agamatrix | 2010-10-18 | Special | PDF ↗ |
| K092875 | ECHO TD-3227 DUAL BLOOD PRESSURE/BLOOD GLUCOSE METER | Taidoc Technology Corporation | 2010-08-13 | Special | PDF ↗ |
| K093262 | AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM | Andon Medical Co., Ltd. | 2010-07-13 | Traditional | PDF ↗ |
| K100732 | FORA G30A BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241 | Taidoc Technology Corporation | 2010-07-09 | Special | PDF ↗ |
| K101457 | EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031 | Eps Bio Technology Corp. | 2010-07-01 | Special | PDF ↗ |
| K100322 | TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277 | Taidoc Technology Corporation | 2010-06-28 | Traditional | PDF ↗ |
| K092052 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM550 | Bionime Corporation | 2010-06-18 | Traditional | PDF ↗ |
| K092638 | FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23 | Abbott Diabetes Care, Inc. | 2010-06-15 | Traditional | PDF ↗ |
| K100398 | SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM | Standard Diagnostics, Inc. | 2010-06-09 | Special | PDF ↗ |
| K093819 | ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER) | Arkray Factory USA, Inc. | 2010-06-09 | Traditional | PDF ↗ |
| K091168 | GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025 | Infopia Co, Ltd. | 2010-05-27 | Traditional | PDF ↗ |
| K092602 | FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2010-05-14 | Traditional | PDF ↗ |
| K100560 | EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277 | Biotest Medical Corp. | 2010-05-12 | Special | PDF ↗ |
| K094005 | FORA G31A/TD-4256A BLOOD GLUCOSE MONITORING SYSTEM AND FORA G31B/TD-4256B BLOOD GLUCOSE MONITORING SYSTEM | Taidoc Technology Corporation | 2010-05-05 | Traditional | PDF ↗ |
| K093940 | ADVOCATE REDI-CODE DASH BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4276 | Taidoc Technology Corporation | 2010-04-23 | Special | PDF ↗ |
| K100701 | SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 6277 | Biotest Medical Corp. | 2010-04-08 | Special | PDF ↗ |
| K091555 | MODEL TD-3252 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM | Taidoc Technology Corporation | 2010-03-15 | Traditional | PDF ↗ |
| K093930 | DIDGET WORLD REPORTS | Bayer Healthcare, LLC | 2010-03-12 | Special | PDF ↗ |
| K092902 | U-RIGHT TD-4238 AND TD-4246 BLOOD GLUCOSE MONITORING SYSTEM FORA G31 BLOOD GLUCOSE MONITORING SYSTEM, TD-4256 BLOOD GLUC | Taidoc Technology Corporation | 2010-03-02 | Special | PDF ↗ |
Product code NBW · Class II · Clinical Chemistry. Data: openFDA.