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 2 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K160682 | CONTOUR NEXT ONE Blood Glucose Monitoring System | Ascensia Diabetes Care | 2016-11-17 | Traditional | PDF ↗ |
| K161738 | FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems | Taidoc Technology Corporation | 2016-11-10 | Traditional | PDF ↗ |
| K160365 | BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System | Infopia Co, Ltd. | 2016-09-28 | Special | PDF ↗ |
| K160944 | ACCU-CHEK Guide Blood Glucose Monitoring System | Roche Diabetes Care, Inc. | 2016-08-31 | Traditional | PDF ↗ |
| K153286 | iHealth Align Gluco-Monitoring system | Andon Health Co, Ltd. | 2016-08-19 | Traditional | PDF ↗ |
| K153278 | Wireless Smart Gluco-Monitoring System | Andon Health Co, Ltd. | 2016-08-19 | Traditional | PDF ↗ |
| K161867 | On Call Pro Blood Glucose Monitoring System | Acon Laboratories | 2016-08-05 | Special | PDF ↗ |
| K160038 | UniStrip1 Generic Blood Glucose Test Strips | Ok Biotech Co., Ltd. | 2016-07-29 | Traditional | PDF ↗ |
| K152599 | PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System | Ok Biotech Co., Ltd. | 2016-07-20 | Traditional | PDF ↗ |
| K160430 | Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System | Ascensia Diabetes Care U.S., Inc. | 2016-06-24 | Special | PDF ↗ |
| K153201 | SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System | Sd Biosensor | 2016-06-24 | Special | PDF ↗ |
| K160156 | StatStrip Xpress Blood Glucose Monitoring System | Nova Biomedical Corporation | 2016-06-23 | Traditional | PDF ↗ |
| K152493 | POGO Automatic Blood Glucose Monitoring System | Intuity Medical, Inc. | 2016-04-25 | Traditional | PDF ↗ |
| K152365 | AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System | Agamatrix, Inc. | 2016-04-21 | Traditional | PDF ↗ |
| K143548 | TRUE METRIX GO Self Monitoring Blood Glucose System | Trividia Health, Inc. | 2016-04-01 | Traditional | PDF ↗ |
| K153330 | FreeStyle Precision Neo H Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2016-02-19 | Traditional | PDF ↗ |
| K143169 | MyGlucoHealth Wireless System | Entra Health Systems | 2016-01-08 | Special | PDF ↗ |
| K150817 | Dario Blood Glucose Monitoring System | Labstyle Innovations, Ltd. | 2015-12-21 | Traditional | PDF ↗ |
| K142785 | PRODIGY iConnect Blood Glucose Monitoring System | Ok Biotech Co., Ltd. | 2015-12-17 | Traditional | PDF ↗ |
| K152442 | Freestyle Freedom Blood Glucose Monitoring Sytem | Abbott Laboratories | 2015-12-17 | Special | PDF ↗ |
| K151611 | OneTouch Ultra Plus Flex Blood Glucose Monitoring System | Lifescan Europe | 2015-12-14 | Traditional | PDF ↗ |
| K150833 | iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System | Andon Health Co, Ltd. | 2015-12-04 | Traditional | PDF ↗ |
| K151658 | Gmate Origin Blood Glucose Monitoring System | Philosys, Inc. | 2015-12-01 | Traditional | PDF ↗ |
| K150942 | Contour Next USB Blood Glucose Monitoring System | Bayer Healthcare | 2015-11-25 | Special | PDF ↗ |
| K151265 | SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring System | Sd Biosensor | 2015-11-24 | Traditional | PDF ↗ |
| K150299 | Gmate SMART Blood Glucose Monitoring System | Philosys, Inc. | 2015-11-19 | Traditional | PDF ↗ |
| K150396 | Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips | Apex BioTechnology Corp. | 2015-10-14 | Special | PDF ↗ |
| K140325 | Joinsoon EON L Glucose Monitoring System and Joinsoon EON LS Glucose Monitoring System | Joinsoon Medical Technology Co, Ltd. | 2015-10-13 | Traditional | PDF ↗ |
| K141656 | GMATE MINI BLOOD GLUCOSE MONITORING SYSTEM, GMATE STEP BLOOD GLUCOSE MONITORING SYSTEM | Philosys, Inc. | 2015-10-02 | Traditional | PDF ↗ |
| K142928 | FreeStyle Precision Neo Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2015-09-30 | Special | PDF ↗ |
| K151100 | U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System | Taidoc Technology Corporation | 2015-09-29 | Special | PDF ↗ |
| K151595 | On Call Express Pro Blood Glucose Monitoring System | ACON Laboratories, Inc. | 2015-09-05 | Traditional | PDF ↗ |
| K150274 | GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System | Infopia Co, Ltd. | 2015-08-26 | Special | PDF ↗ |
| K151164 | Assure Prism multi Blood Glucose Monitoring System | I-Sens, Inc. | 2015-08-07 | Special | PDF ↗ |
| K132929 | SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVII MENTOR NFC BLOOD GLUCOSE MONITORING SYSTEM | Sd Biosensor, Inc. | 2015-08-05 | Traditional | PDF ↗ |
| K150214 | OneTouch Verio Flex Blood Glucose Monitoring System | Lifescan Europe | 2015-07-31 | Traditional | PDF ↗ |
| K141292 | Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System GM650, GE200 Blood Glucose Monitoring System, and GE300 Talking Blood Glucose Monitoring System | Bionime Coporation | 2015-06-09 | Traditional | PDF ↗ |
| K150332 | FreeStyle Lite Blood Glucose Monitoring System | Abbott Laboratories | 2015-06-05 | Special | PDF ↗ |
| K150531 | FreeStyle Freedom Lite Blood Glucose Monitoring System | Abbott Laboratories | 2015-06-05 | Special | PDF ↗ |
| K143387 | GE333 Blood Glucose Monitoring System | Bionime Coporation | 2015-06-03 | Traditional | PDF ↗ |
| K140068 | CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM | Polymer Technology Systems, Inc. | 2015-05-22 | Special | PDF ↗ |
| K141351 | SUPERCHECK PLUS BLOOD GLUCOSE MONITORING SYSTEM, SUPER CHECK PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM | Biotest Medical Corp. | 2015-05-19 | Traditional | PDF ↗ |
| K140150 | Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife AC-302 Blood Glucose Monitoring System, Goodlife AC 303 Blood Glucose Monitoring System, Goodlife AC-304 Blood Glucose Monitoring System Goodlife AC-305 Blood Glucose Monitoring System, Goodlife AC-300 Professional Blood Glucose Monitoring System, Goodlife AC-301 Professional Blood Glucose Monitoring System Goodlife AC-30 | Hmd Biomedical, Inc. | 2015-05-14 | Special | PDF ↗ |
| K143467 | FORA GD43 Blood Glucose Monitoring System | Taidoc Technology Corporation | 2015-05-07 | Traditional | PDF ↗ |
| K141036 | BGM009 BLOOD GLUCOSE MONITORING SYSTEM | Apex BioTechnology Corp. | 2015-05-01 | Traditional | PDF ↗ |
| K132663 | I-QARE DS-W BLOOD GLUCOSE MONITORING SYSTEM | Alliance International Co., Ltd. | 2015-04-20 | Traditional | PDF ↗ |
| K141914 | PRODIGY AUTOCODE EJECT BLOOD GLUCOSE MONITORING SYSTEM | Ok Biotech Co., Ltd. | 2015-04-15 | Traditional | PDF ↗ |
| K150052 | TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional Blood Gulcose Monitoring System | Nipro Diagnostics, Inc. | 2015-03-26 | Special | PDF ↗ |
| K141867 | ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM | Roche Diagnostics | 2015-03-03 | Special | PDF ↗ |
| K141862 | HEALTH2SYNC MOBILE APPLICATION, HEALTH2SYNC SMART CABLE | H2, Inc. | 2014-12-02 | Traditional | PDF ↗ |
| K140371 | FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT), TEST STRIPS (100CT) | Abbott Diabetes Care, Inc. | 2014-09-30 | Traditional | PDF ↗ |
| K141829 | GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM | Ceragem Medisys, Inc. | 2014-09-24 | Special | PDF ↗ |
| K131173 | FIA Blood Glucose Monitoring System (G2) | Hmd Biomedical, Inc. | 2014-09-18 | Traditional | PDF ↗ |
| K142035 | GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE MONITORING SYSTEM | Arkray Factory, Inc. | 2014-09-05 | Traditional | PDF ↗ |
| K133741 | ACCU-CHEK Performa Blood Glucose Monitoring System | Roche Diagnostics | 2014-08-29 | Traditional | PDF ↗ |
| K140210 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS GM720 | Bionime Corporation | 2014-08-22 | Traditional | PDF ↗ |
| K132633 | OKMETER DIRECT BLOOD GLUCOSE MONITORING SYSTEM | Ok Biotech Co., Ltd. | 2014-08-14 | Traditional | PDF ↗ |
| K131230 | GMATE SMART BLOOD GLUCOSE MONITORING SYSTEM, GMATE SMART APPLICATION | Philosys, Inc. | 2014-08-04 | Traditional | PDF ↗ |
| K140100 | TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM | Nipro Diagnostics, Inc. | 2014-08-01 | Traditional | PDF ↗ |
| K140141 | LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM | Ceragem Medisys, Inc. | 2014-07-03 | Special | PDF ↗ |
| K133260 | MEDISIGN BLOOD GLUCSE MONITORING SYSTEM, MEDISIGN MULTI BLOOD GLUCOSE MONITORING SYSTEM | Tianjin Empecs Medical Device Co., Ltd. | 2014-06-27 | Traditional | PDF ↗ |
| K132180 | IDEAL LIFE GLUCO-MANAGER BLOOD GLUCOSE MONITORING SYSTEM | Ideal Life, Inc. | 2014-06-25 | Traditional | PDF ↗ |
| K130265 | CONTOUR NEXT EZ BLOOD GLUCOSE METER | Bayer Healthcare, LLC | 2014-06-23 | Traditional | PDF ↗ |
| K133790 | IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM | Andon Health Co, Ltd. | 2014-05-22 | Special | PDF ↗ |
| K133862 | ACCU-CHEK AVIVA PLUS SYSTEM | Roche Diagnostics Corporation | 2014-04-29 | Special | PDF ↗ |
| K132406 | ELEMENTV BLOOD GLUCOSE MONITORING SYSTEM | Infopia Co, Ltd. | 2014-04-18 | Traditional | PDF ↗ |
| K133522 | RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM | Bionime Coporation | 2014-04-17 | Traditional | PDF ↗ |
| K133389 | EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM | Eps Bio Technology Corp. | 2014-04-15 | Special | PDF ↗ |
| K133045 | ELEMENT TM LITE BLOOD GLUCOSE MONITORING SYSTEM | Infopia Co, Ltd. | 2014-04-10 | Traditional | PDF ↗ |
| K133647 | EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM | Eps Bio Technology Corp. | 2014-02-27 | Special | PDF ↗ |
| K133509 | EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE MONITORING SYSTEM,SMARTEST PERSONA II BLOO | Biotest Medical Corp. | 2014-02-21 | Special | PDF ↗ |
| K123517 | GLUCOMENTOR BLOOD GLUCOSE MONITORING SYSTEM, GLUCOMENTOR MULTI BLOOD GLUCOSE MONITORING SYSTEM | Sd Biosensor | 2014-01-17 | Special | PDF ↗ |
| K131469 | ACON ON CALL DIABETES MANAGEMENT SOFTWARE | ACON Laboratories, Inc. | 2014-01-06 | Special | PDF ↗ |
| K132511 | FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM | Abbott Diabetes Care, Inc. | 2013-12-24 | Special | PDF ↗ |
| K130284 | ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM | ACON Laboratories, Inc. | 2013-12-20 | Traditional | PDF ↗ |
| K133346 | SMARTLOG DIABETES MANAGEMENT SOFTWARE | I-Sens, Inc. | 2013-12-19 | Special | PDF ↗ |
| K132086 | ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM | ACON Laboratories, Inc. | 2013-12-19 | Traditional | PDF ↗ |
| K132862 | HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM | Infopia Co, Ltd. | 2013-12-12 | Special | PDF ↗ |
| K132966 | GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM | Infopia Co, Ltd. | 2013-12-05 | Traditional | PDF ↗ |
| K122340 | PRODIGY CHOICE | Prodigy Diabetes Care, LLC | 2013-11-26 | Traditional | PDF ↗ |
| K123090 | GLB BENECHECK PREMIUM GLU MONITORING SYSTEM | General Life Biotechnology Co., Ltd. | 2013-11-22 | Traditional | PDF ↗ |
| K132288 | CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER | I-Sens, Inc. | 2013-11-22 | Special | PDF ↗ |
| K132821 | AGAMATRIX HEALTH MANAGER | Agamatrix, Inc. | 2013-11-20 | Special | PDF ↗ |
| K113135 | UNISTRIP 1 | Unistrip Technologies, LLC | 2013-11-06 | Traditional | PDF ↗ |
| K122338 | PREFERRED BLOOD GLUCOSE MONITORING SYSTEM | Prodigy Diabetes Care, LLC | 2013-11-05 | Traditional | PDF ↗ |
| K132338 | DA01 BLOOD GLUCOSE MONITORING SYSTEM | Delbio Incorporation | 2013-10-24 | Special | PDF ↗ |
| K132272 | GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION | Glooko, Inc. | 2013-10-17 | Special | PDF ↗ |
| K131013 | FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM | Nova Biomedical Corporation | 2013-10-17 | Traditional | PDF ↗ |
| K122370 | CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR | Bayer Healthcare | 2013-09-26 | Traditional | PDF ↗ |
| K131363 | ONETOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM | Cilag GmbH International | 2013-08-30 | Traditional | PDF ↗ |
| K130244 | DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM | Delbio Incorporation | 2013-08-23 | Traditional | PDF ↗ |
| K130696 | CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM; CARESENS N LINK MULTI BLOOD BLUCOSE MONITORING SYSTEM | I-Sens, Inc. | 2013-08-21 | Traditional | PDF ↗ |
| K122181 | EBCHEK BLOOD GLUCOSE MONITORING SYSTEM | Visgeneer, Inc. | 2013-08-15 | Traditional | PDF ↗ |
| K132072 | TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRI PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM | Nipro Diagnostics, Inc. | 2013-08-15 | Special | PDF ↗ |
| K131419 | ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM | I-Sens, Inc. | 2013-08-09 | Special | PDF ↗ |
| K131029 | ACCU-CHEK AVIVA PLUS TEST STRIP | Roche Diagnostics Operations, Inc. | 2013-08-09 | Special | PDF ↗ |
| K130181 | GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM | Infopia Co, Ltd. | 2013-07-31 | Traditional | PDF ↗ |
| K130621 | BROADMASTER HEALTHCARE SYSTEM | Broadmaster Biotech Corporation | 2013-07-30 | Traditional | PDF ↗ |
| K130657 | LINKDR 2.0 DIABETES MANAGEMENT SOFTWARE | All Medicus Co., Ltd. | 2013-07-15 | Traditional | PDF ↗ |
| K123559 | SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM | Biotest Medical Corp. | 2013-06-28 | Traditional | PDF ↗ |
Product code NBW · Class II · Clinical Chemistry. Data: openFDA.