NBW · System, Test, Blood Glucose, Over The Counter
Clinical Chemistry · 21 CFR 862.1345 · Class 2
Overview
| Product Code | NBW |
|---|---|
| Device Name | System, Test, Blood Glucose, Over The Counter |
| Regulation | 21 CFR 862.1345 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
Identification
A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Classification Rationale
Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Cleared Devices (508)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250085 | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System | ACON Laboratories, Inc. | Oct 10, 2025 | SESE |
| K243060 | TeleRPM Gen2 Blood Glucose Monitoring System | Guangdong Transtek Medical Electronics Co., Ltd. | Jan 30, 2025 | SESE |
| K240637 | RIGHTEST Blood Glucose Monitoring System Max Tel | Bionime Corporation | Nov 4, 2024 | SESE |
| K240640 | Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System | Sejoy Biomedical Co., Ltd. | Oct 8, 2024 | SESE |
| K241787 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System | Ascensia Diabetes Care U.S., Inc. | Aug 27, 2024 | SESE |
| K222126 | VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose Monitoring System, VivaChek Fad Sync Blood Glucose Monitoring System | Vivachek Biotech (Hangzhou) Co., Ltd. | Aug 16, 2024 | SESE |
| K241304 | WaveSense Jazz Blood Glucose Monitoring System | Agamatrix | Jun 6, 2024 | SESE |
| K231679 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System | Ascensia Diabetes Care | Feb 23, 2024 | SESE |
| K231192 | RIGHTEST Blood Glucose Monitoring System Max Tel | Bionime Corporation | Jan 19, 2024 | SESE |
| K233058 | VivaChek Link Plus Blood Glucose Monitoring System | Vivachek Biotech (Hangzhou) Co., Ltd. | Dec 22, 2023 | SESE |
| K231476 | TRUENESS AIR Blood Glucose Monitoring System; TRUENESS Blood Glucose Monitoring System | Sinocare, Inc. | Dec 1, 2023 | SESE |
| K230625 | ReliOn Premier BLU Blood Glucose Monitoring System | I-Sens, Inc. | Aug 10, 2023 | SESE |
| K213131 | Accu-Chek Guide Solo diabetes manager blood glucose monitoring system | Roche Diabetes Care GmbH | Aug 10, 2023 | SESE |
| K223722 | MIO Blood Glucose Monitoring System | Mio Labs, Inc. | Jun 28, 2023 | SESE |
| K222234 | GlucoSure ADVANCE Link Blood Glucose Monitoring System | Apex BioTechnology Corp. | Dec 21, 2022 | SESE |
| K223293 | CONTOUR® NEXT GEN Blood Glucose Monitoring System | Ascensia Diabetes Care U.S., Inc. | Nov 18, 2022 | SESE |
| K220421 | BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System | Apex BioTechnology Corp. | Nov 4, 2022 | SESE |
| K213061 | SuperCheck Pro Blood Glucose Monitoring System | Ok Biotech Co., Ltd. | Oct 7, 2022 | SESE |
| K212248 | GlucoLeader Enhance 2 Blood Glucose Monitoring System | Hmd Biomedical, Inc. | Aug 29, 2022 | SESE |
| K212140 | GlucoSure Link Blood Glucose Monitoring System | Apex BioTechnology Corp. | Aug 25, 2022 | SESE |
| K202739 | Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System | Bioland Technology, Ltd. | Aug 12, 2022 | SESE |
| K201037 | FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System | Taidoc Technology Corporation | Jun 16, 2022 | SESE |
| K203711 | IWL2020 Blood Glucose Monitoring System | Roche Diabetes Care, Inc. | May 6, 2022 | SESE |
| K202534 | MTM301 Blood Glucose and Ketone Monitoring System | Apex BioTechnology Corp. | Apr 6, 2022 | SESE |
| K213887 | GAL-1A Plus Blood Glucose Monitoring System | Apex BioTechnology Corp. | Mar 29, 2022 | SESE |
| K193406 | CardioChek Plus Test System; CardioChek Plus Home Test System | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics | Feb 26, 2022 | SESE |
| K193407 | Contour® next GEN Blood Glucose Monitoring System | Ascensia Diabetes Care | Dec 23, 2021 | SESE |
| K201880 | MultiSure GK Link Blood Glucose and Ketone Monitoring System | Apex BioTechnology Corp. | Oct 15, 2021 | SESE |
| K201394 | CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System | I-Sens, Inc. | Oct 5, 2021 | SESE |
| K202885 | GlucoSure HT Plus Blood Glucose Monitoring System | Apex BioTechnology Corp. | Sep 15, 2021 | SESE |
| K201258 | EASYMAX Tag Self-Monitoring Blood Glucose System | Eps Bio Technology Corp. | Sep 1, 2021 | SESE |
| K210687 | CONTOUR® NEXT ONE Blood Glucose Monitoring System | Ascensia Diabetes Care | Aug 11, 2021 | SESE |
| K203562 | Finetest Lite Blood Glucose Monitoring System | Osang Healthcare Co. , Ltd. | Jul 13, 2021 | SESE |
| K201396 | Finetest Lite Smart Blood Glucose Monitoring System | Osang Healthcare Co. , Ltd. | Oct 16, 2020 | SESE |
| K193340 | GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System | Microtech Medical, Inc. | Sep 11, 2020 | SESE |
| K200277 | Livongo Blood Glucose Monitoring System (BG1000) | Livongo Health, Inc. | Jun 4, 2020 | SESE |
| K191657 | Bioland Blood Glucose Monitoring System | Bioland Technology, Ltd. | Mar 20, 2020 | SESE |
| K193475 | OneTouch Verio Reflect Blood Glucose Monitoring System | Lifescan Europe GmbH | Feb 14, 2020 | SESE |
| K192859 | CareSens S Clear BT Blood Glucose Monitoring System | I-Sens, Inc. | Jan 24, 2020 | SESE |
| K193590 | CareSens S Fit BT Blood Glucose Monitoring System | I-Sens, Inc. | Jan 17, 2020 | SESE |
| K192220 | ReliOn Premier Classic Blood Glucose Monitoring System | I-Sens, Inc. | Dec 13, 2019 | SESE |
| K191286 | CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System | Ascensia Diabetes Care | Nov 8, 2019 | SESE |
| K190189 | MDT2 BLE Self-Monitoring Blood Glucose System | Eps Bio Technology Corp. | Nov 1, 2019 | SESE |
| K192175 | On Call Express II Blood Glucose Monitoring System | ACON Laboratories, Inc. | Oct 17, 2019 | SESE |
| K191038 | On Call Express Voice Blood Glucose Monitoring System | ACON Laboratories, Inc. | Jun 12, 2019 | SESE |
| K190579 | TD-4183 Blood Glucose Monitoring System | Taidoc Technology Corporation | Jun 4, 2019 | SESE |
| K190564 | Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB | Bionime Corporation | Jun 2, 2019 | SESE |
| K182428 | GlucoLeader Enhance Blood Glucose Monitoring System | Hmd Biomedical, Inc. | May 8, 2019 | SESE |
| K183306 | GLUCOCARD® W onyx Blood Glucose Monitoring System | Arkray Factory, Inc. | Apr 10, 2019 | SESE |
| K181070 | iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) | Andon Health Co, Ltd. | Feb 1, 2019 | SESE |
| K173140 | VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Monitoring System, VivaChek Ino Sound Bright Blood Glucose Monitoring System | Vivachek Laboratories, Inc. | Dec 19, 2018 | SESE |
| K181131 | Accu-Chek Guide Me Blood Glucose Monitoring System | Roche Diabetes Care | Dec 13, 2018 | SESE |
| K182046 | Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System | Tyson Bioresearch, Inc. | Nov 30, 2018 | SESE |
| K181588 | POPS! one Blood Glucose Monitoring System | Taidoc Technology Corporation | Nov 30, 2018 | SESE |
| K182047 | Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System | Tyson Bioresearch, Inc. | Nov 29, 2018 | SESE |
| K182992 | BGM014 Blood Glucose Monitoring System | Apex BioTechnology Corp. | Nov 28, 2018 | SESE |
| K181273 | GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System | I-Sens, Inc. | Nov 1, 2018 | SESE |
| K181527 | On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System | ACON Laboratories, Inc. | Oct 3, 2018 | SESE |
| K182286 | Oh'Care Lite Smart Blood Glucose Monitoring System | Osang Healthcare Co. , Ltd. | Sep 19, 2018 | SESE |
| K180866 | CareSens S Fit Blood Glucose Monitoring System | I-Sens, Inc. | Aug 31, 2018 | SESE |
| K182057 | EasyMax BT Self-Monitoring Blood Glucose System | Eps Bio Technology Corp. | Aug 24, 2018 | SESE |
| K173658 | Confidence Blood Glucose Monitoring System | Applied Biomedical, LLC | Aug 21, 2018 | SESE |
| K173638 | Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus | Bionime Corporation | Aug 17, 2018 | SESE |
| K173505 | FORA GTel Blood Glucose Monitoring System | Foracare, Inc. | Aug 9, 2018 | SESE |
| K173511 | ActiveCare TD-4121 Blood Glucose Monitoring System | Taidoc Technology Corporation | Jul 12, 2018 | SESE |
| K173139 | Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus | Bionime Corporation | Jun 19, 2018 | SESE |
| K181316 | POGO Automatic Blood Glucose Monitoring System | Intuity Medical, Inc. | Jun 14, 2018 | SESE |
| K172723 | Dario LC Blood Glucose Monitoring System | Labstyle Innovation, Ltd. | Mar 23, 2018 | SESE |
| K180196 | On Call Express Mobile Blood Glucose Monitoring System | ACON Laboratories, Inc. | Mar 7, 2018 | SESE |
| K171480 | NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System | I-Sens, Inc. | Dec 13, 2017 | SESE |
| K170464 | StatStrip Xpress Blood Glucose Monitoring System | Nova Biomedical Corporation | Nov 7, 2017 | SESE |
| K163087 | PixoTest Blood Glucose Monitoring System | Ixensor Company , Ltd. | Nov 2, 2017 | SESE |
| K170614 | CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System | I-Sens, Inc. | Oct 19, 2017 | SESE |
| K160282 | SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System | Sd Biosensor | Oct 17, 2017 | SESE |
| K170241 | GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring System | All Medicus Co., Ltd. | Oct 13, 2017 | SESE |
| K170079 | Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System | Tyson Bioresearch, Inc. | Oct 6, 2017 | SESE |
| K170264 | Gold AQ Blood Glucose Monitoring System | Changsha Sinocare, Inc. | Oct 5, 2017 | SESE |
| K171941 | FreeStyle Precision Neo Blood Glucose Test Strips | Abbott Diabetes Care, Inc. | Sep 27, 2017 | SESE |
| K171822 | NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) | Biotest Medical Corporation | Sep 20, 2017 | SESE |
| K171785 | WowGoHealth Blood Glucose Monitoring System | Biotest Medical Corporation | Sep 15, 2017 | SESE |
| K170231 | iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5) | Andon Health Co, Ltd. | Sep 15, 2017 | SESE |
| K170064 | GLUCOCARD W Blood Glucose Monitoring System | Arkray Factory, Inc. | Aug 16, 2017 | SESE |
| K163159 | Dario Blood Glucose Monitoring System | Labstyle Innovations, Ltd. | Jul 19, 2017 | SESE |
| K170143 | GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B, | Bionime Corporation | Jul 6, 2017 | SESE |
| K162564 | Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring System, Medisign GH83 Blood Glucose Monitoring System, Medisign GH81 BT Blood Glucose Monitoring System, Medisign GH82 BT Blood Glucose Monitoring System, Medisign GH83 BT Blood Glucose Monitoring System | Tianjin Empecs Medical Device Co., Ltd. | Jun 7, 2017 | SESE |
| K161790 | iGlucose Blood Glucose Monitoring System | Bionime Corporation | May 2, 2017 | SESE |
| K160179 | VivaChek Ino Blood Glucose Monitoring System | Vivachek Laboratories, Inc. | Apr 21, 2017 | SESE |
| K162382 | Smart Dongle Blood Glucose Monitoring System | Taidoc Technology Corporation | Apr 14, 2017 | SESE |
| K162203 | POGO Automatic Blood Glucose Monitoring System | Intuity Medical, Inc. | Apr 6, 2017 | SESE |
| K152534 | Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose Monitoring System, Medisign MM1200 BT Blood Glucose Monitoring System, Smart Diabetes Bluetooth Blood Glucose Monitoring System, Medisign MM 1000 BT MULTI Blood Glucose Monitoring System, Medisign MM 1100 BT MULTI Blood Glucose Monitoring System, Medisign MM 1200 BT MULTI Blood Glucose Monitoring System, Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System | Tianjin Empecs Medical Device Co., Ltd. | Mar 21, 2017 | SESE |
| K170267 | BGM009 Plus Blood Glucose Monitoring System | Apex BioTechnology Corp. | Mar 9, 2017 | SESE |
| K153561 | AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System | Andon Health Co, Ltd. | Feb 16, 2017 | SESE |
| K162430 | UniStrip1 Generic Blood Glucose Test Strips | Ok Biotech Co., Ltd. | Jan 19, 2017 | SESE |
| K162336 | Contour Next EZ Blood Glucose Monitoring System | Ascensia Diabetes Care U.S., Inc. | Jan 12, 2017 | SESE |
| K161299 | BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System | Apex BioTechnology Corp. | Dec 23, 2016 | SESE |
| K160742 | NoCoding1 Plus Blood Glucose Monitoring System | I-Sens, Inc. | Dec 16, 2016 | SESE |
| K161834 | One Drop Blood Glucose Monitoring System | Agamatrix, Inc. | Nov 30, 2016 | SESE |
| K160682 | CONTOUR NEXT ONE Blood Glucose Monitoring System | Ascensia Diabetes Care | Nov 17, 2016 | SESE |
| K161738 | FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems | Taidoc Technology Corporation | Nov 10, 2016 | SESE |
| K160365 | BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System | Infopia Co, Ltd. | Sep 28, 2016 | SESE |
| K160944 | ACCU-CHEK Guide Blood Glucose Monitoring System | Roche Diabetes Care, Inc. | Aug 31, 2016 | SESE |
| K153286 | iHealth Align Gluco-Monitoring system | Andon Health Co, Ltd. | Aug 19, 2016 | SESE |
| K153278 | Wireless Smart Gluco-Monitoring System | Andon Health Co, Ltd. | Aug 19, 2016 | SESE |
| K161867 | On Call Pro Blood Glucose Monitoring System | Acon Laboratories | Aug 5, 2016 | SESE |
| K160038 | UniStrip1 Generic Blood Glucose Test Strips | Ok Biotech Co., Ltd. | Jul 29, 2016 | SESE |
| K152599 | PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System | Ok Biotech Co., Ltd. | Jul 20, 2016 | SESE |
| K160430 | Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System | Ascensia Diabetes Care U.S., Inc. | Jun 24, 2016 | SESE |
| K153201 | SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System | Sd Biosensor | Jun 24, 2016 | SESE |
| K160156 | StatStrip Xpress Blood Glucose Monitoring System | Nova Biomedical Corporation | Jun 23, 2016 | SESE |
| K152493 | POGO Automatic Blood Glucose Monitoring System | Intuity Medical, Inc. | Apr 25, 2016 | SESE |
| K152365 | AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System | Agamatrix, Inc. | Apr 21, 2016 | SESE |
| K143548 | TRUE METRIX GO Self Monitoring Blood Glucose System | Trividia Health, Inc. | Apr 1, 2016 | SESE |
| K153330 | FreeStyle Precision Neo H Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | Feb 19, 2016 | SESE |
| K143169 | MyGlucoHealth Wireless System | Entra Health Systems | Jan 8, 2016 | SESE |
| K150817 | Dario Blood Glucose Monitoring System | Labstyle Innovations, Ltd. | Dec 21, 2015 | SESE |
| K152442 | Freestyle Freedom Blood Glucose Monitoring Sytem | Abbott Laboratories | Dec 17, 2015 | SESE |
| K142785 | PRODIGY iConnect Blood Glucose Monitoring System | Ok Biotech Co., Ltd. | Dec 17, 2015 | SESE |
| K151611 | OneTouch Ultra Plus Flex Blood Glucose Monitoring System | Lifescan Europe | Dec 14, 2015 | SESE |
| K150833 | iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System | Andon Health Co, Ltd. | Dec 4, 2015 | SESE |
| K151658 | Gmate Origin Blood Glucose Monitoring System | Philosys, Inc. | Dec 1, 2015 | SESE |
| K150942 | Contour Next USB Blood Glucose Monitoring System | Bayer Healthcare | Nov 25, 2015 | SESE |
| K151265 | SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring System | Sd Biosensor | Nov 24, 2015 | SESE |
| K150299 | Gmate SMART Blood Glucose Monitoring System | Philosys, Inc. | Nov 19, 2015 | SESE |
| 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. | Oct 14, 2015 | SESE |
| K140325 | Joinsoon EON L Glucose Monitoring System and Joinsoon EON LS Glucose Monitoring System | Joinsoon Medical Technology Co, Ltd. | Oct 13, 2015 | SESE |
| K141656 | GMATE MINI BLOOD GLUCOSE MONITORING SYSTEM, GMATE STEP BLOOD GLUCOSE MONITORING SYSTEM | Philosys, Inc. | Oct 2, 2015 | SESE |
| K142928 | FreeStyle Precision Neo Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | Sep 30, 2015 | SESE |
| K151100 | U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System | Taidoc Technology Corporation | Sep 29, 2015 | SESE |
| K151595 | On Call Express Pro Blood Glucose Monitoring System | ACON Laboratories, Inc. | Sep 5, 2015 | SESE |
| K150274 | GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System | Infopia Co, Ltd. | Aug 26, 2015 | SESE |
| K151164 | Assure Prism multi Blood Glucose Monitoring System | I-Sens, Inc. | Aug 7, 2015 | SESE |
| K132929 | SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVII MENTOR NFC BLOOD GLUCOSE MONITORING SYSTEM | Sd Biosensor, Inc. | Aug 5, 2015 | SESE |
| K150214 | OneTouch Verio Flex Blood Glucose Monitoring System | Lifescan Europe | Jul 31, 2015 | SESE |
| 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 | Jun 9, 2015 | SESE |
| K150531 | FreeStyle Freedom Lite Blood Glucose Monitoring System | Abbott Laboratories | Jun 5, 2015 | SESE |
| K150332 | FreeStyle Lite Blood Glucose Monitoring System | Abbott Laboratories | Jun 5, 2015 | SESE |
| K143387 | GE333 Blood Glucose Monitoring System | Bionime Coporation | Jun 3, 2015 | SESE |
| K140068 | CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM | Polymer Technology Systems, Inc. | May 22, 2015 | SESE |
| K141351 | SUPERCHECK PLUS BLOOD GLUCOSE MONITORING SYSTEM, SUPER CHECK PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM | Biotest Medical Corp. | May 19, 2015 | SESE |
| 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. | May 14, 2015 | SESE |
| K143467 | FORA GD43 Blood Glucose Monitoring System | Taidoc Technology Corporation | May 7, 2015 | SESE |
| K141036 | BGM009 BLOOD GLUCOSE MONITORING SYSTEM | Apex BioTechnology Corp. | May 1, 2015 | SESE |
| K132663 | I-QARE DS-W BLOOD GLUCOSE MONITORING SYSTEM | Alliance International Co., Ltd. | Apr 20, 2015 | SESE |
| K141914 | PRODIGY AUTOCODE EJECT BLOOD GLUCOSE MONITORING SYSTEM | Ok Biotech Co., Ltd. | Apr 15, 2015 | SESE |
| K150052 | TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional Blood Gulcose Monitoring System | Nipro Diagnostics, Inc. | Mar 26, 2015 | SESE |
| K141867 | ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM | Roche Diagnostics | Mar 3, 2015 | SESE |
| K141862 | HEALTH2SYNC MOBILE APPLICATION, HEALTH2SYNC SMART CABLE | H2, Inc. | Dec 2, 2014 | SESE |
| K140371 | FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT), TEST STRIPS (100CT) | Abbott Diabetes Care, Inc. | Sep 30, 2014 | SESE |
| K141829 | GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM | Ceragem Medisys, Inc. | Sep 24, 2014 | SESE |
| K131173 | FIA Blood Glucose Monitoring System (G2) | Hmd Biomedical, Inc. | Sep 18, 2014 | SESE |
| K142035 | GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE MONITORING SYSTEM | Arkray Factory, Inc. | Sep 5, 2014 | SESE |
| K133741 | ACCU-CHEK Performa Blood Glucose Monitoring System | Roche Diagnostics | Aug 29, 2014 | SESE |
| K140210 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS GM720 | Bionime Corporation | Aug 22, 2014 | SESE |
| K132633 | OKMETER DIRECT BLOOD GLUCOSE MONITORING SYSTEM | Ok Biotech Co., Ltd. | Aug 14, 2014 | SESE |
| K131230 | GMATE SMART BLOOD GLUCOSE MONITORING SYSTEM, GMATE SMART APPLICATION | Philosys, Inc. | Aug 4, 2014 | SESE |
| K140100 | TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM | Nipro Diagnostics, Inc. | Aug 1, 2014 | SESE |
| K140141 | LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM | Ceragem Medisys, Inc. | Jul 3, 2014 | SESE |
| K133260 | MEDISIGN BLOOD GLUCSE MONITORING SYSTEM, MEDISIGN MULTI BLOOD GLUCOSE MONITORING SYSTEM | Tianjin Empecs Medical Device Co., Ltd. | Jun 27, 2014 | SESE |
| K132180 | IDEAL LIFE GLUCO-MANAGER BLOOD GLUCOSE MONITORING SYSTEM | Ideal Life, Inc. | Jun 25, 2014 | SESE |
| K130265 | CONTOUR NEXT EZ BLOOD GLUCOSE METER | Bayer Healthcare, LLC | Jun 23, 2014 | SESE |
| K133790 | IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM | Andon Health Co, Ltd. | May 22, 2014 | SESE |
| K133862 | ACCU-CHEK AVIVA PLUS SYSTEM | Roche Diagnostics Corporation | Apr 29, 2014 | SESE |
| K132406 | ELEMENTV BLOOD GLUCOSE MONITORING SYSTEM | Infopia Co, Ltd. | Apr 18, 2014 | SESE |
| K133522 | RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM | Bionime Coporation | Apr 17, 2014 | SESE |
| K133389 | EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM | Eps Bio Technology Corp. | Apr 15, 2014 | SESE |
| K133045 | ELEMENT TM LITE BLOOD GLUCOSE MONITORING SYSTEM | Infopia Co, Ltd. | Apr 10, 2014 | SESE |
| K133647 | EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM | Eps Bio Technology Corp. | Feb 27, 2014 | SESE |
| K133509 | EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE MONITORING SYSTEM,SMARTEST PERSONA II BLOO | Biotest Medical Corp. | Feb 21, 2014 | SESE |
| K123517 | GLUCOMENTOR BLOOD GLUCOSE MONITORING SYSTEM, GLUCOMENTOR MULTI BLOOD GLUCOSE MONITORING SYSTEM | Sd Biosensor | Jan 17, 2014 | SESE |
| K131469 | ACON ON CALL DIABETES MANAGEMENT SOFTWARE | ACON Laboratories, Inc. | Jan 6, 2014 | SESE |
| K132511 | FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM | Abbott Diabetes Care, Inc. | Dec 24, 2013 | SESE |
| K130284 | ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM | ACON Laboratories, Inc. | Dec 20, 2013 | SESE |
| K133346 | SMARTLOG DIABETES MANAGEMENT SOFTWARE | I-Sens, Inc. | Dec 19, 2013 | SESE |
| K132086 | ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM | ACON Laboratories, Inc. | Dec 19, 2013 | SESE |
| K132862 | HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM | Infopia Co, Ltd. | Dec 12, 2013 | SESE |
| K132966 | GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM | Infopia Co, Ltd. | Dec 5, 2013 | SESE |
| K122340 | PRODIGY CHOICE | Prodigy Diabetes Care, LLC | Nov 26, 2013 | SESE |
| K132288 | CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER | I-Sens, Inc. | Nov 22, 2013 | SESE |
| K123090 | GLB BENECHECK PREMIUM GLU MONITORING SYSTEM | General Life Biotechnology Co., Ltd. | Nov 22, 2013 | SESE |
| K132821 | AGAMATRIX HEALTH MANAGER | Agamatrix, Inc. | Nov 20, 2013 | SESE |
| K113135 | UNISTRIP 1 | Unistrip Technologies, LLC | Nov 6, 2013 | SESE |
| K122338 | PREFERRED BLOOD GLUCOSE MONITORING SYSTEM | Prodigy Diabetes Care, LLC | Nov 5, 2013 | SESE |
| K132338 | DA01 BLOOD GLUCOSE MONITORING SYSTEM | Delbio Incorporation | Oct 24, 2013 | SESE |
| K132272 | GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION | Glooko, Inc. | Oct 17, 2013 | SESE |
| K131013 | FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM | Nova Biomedical Corporation | Oct 17, 2013 | SESE |
| K122370 | CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR | Bayer Healthcare | Sep 26, 2013 | SESE |
| K131363 | ONETOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM | Cilag GmbH International | Aug 30, 2013 | SESE |
| K130244 | DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM | Delbio Incorporation | Aug 23, 2013 | SESE |
| K130696 | CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM; CARESENS N LINK MULTI BLOOD BLUCOSE MONITORING SYSTEM | I-Sens, Inc. | Aug 21, 2013 | SESE |
| K132072 | TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRI PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM | Nipro Diagnostics, Inc. | Aug 15, 2013 | SESE |
| K122181 | EBCHEK BLOOD GLUCOSE MONITORING SYSTEM | Visgeneer, Inc. | Aug 15, 2013 | SESE |
| K131419 | ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM | I-Sens, Inc. | Aug 9, 2013 | SESE |
| K131029 | ACCU-CHEK AVIVA PLUS TEST STRIP | Roche Diagnostics Operations, Inc. | Aug 9, 2013 | SESE |
| K130181 | GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM | Infopia Co, Ltd. | Jul 31, 2013 | SESE |
| K130621 | BROADMASTER HEALTHCARE SYSTEM | Broadmaster Biotech Corporation | Jul 30, 2013 | SESE |
| K130657 | LINKDR 2.0 DIABETES MANAGEMENT SOFTWARE | All Medicus Co., Ltd. | Jul 15, 2013 | SESE |
| K123559 | SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM | Biotest Medical Corp. | Jun 28, 2013 | SESE |
| K130094 | FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM | Abbott Diabetes Care | Jun 27, 2013 | SESE |
| K130295 | LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM. | Infopia Co, Ltd. | Jun 21, 2013 | SESE |
| K123007 | VERI-Q MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM, VERI-Q PLUS MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM | Mico Biomed Co., Ltd. | Jun 19, 2013 | SESE |
Top Applicants
- Taidoc Technology Corporation — 65 clearances
- I-Sens, Inc. — 21 clearances
- Bionime Corporation — 18 clearances
- Apex BioTechnology Corp. — 18 clearances
- Abbott Diabetes Care, Inc. — 18 clearances
