System, Test, Blood Glucose, Over The Counter

NBW 2026-07-23

TRUE METRIX Self Monitoring Blood Glucose System

Applicant Trividia Health, Inc.

K number K262116

NBW 2025-10-10

On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System

Applicant ACON Laboratories, Inc.

K number K250085

NBW 2025-01-30

TeleRPM Gen2 Blood Glucose Monitoring System

Applicant Guangdong Transtek Medical Electronics Co., Ltd.

K number K243060

NBW 2024-11-04

RIGHTEST Blood Glucose Monitoring System Max Tel

Applicant Bionime Corporation

K number K240637

NBW 2024-10-08

Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System

Applicant Sejoy Biomedical Co., Ltd.

K number K240640

NBW 2024-08-27

CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System

Applicant Ascensia Diabetes Care U.S., Inc.

K number K241787

NBW 2024-08-16

VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring System

Applicant Vivachek Biotech (Hangzhou) Co., Ltd.

K number K222126

NBW 2024-06-06

WaveSense Jazz Blood Glucose Monitoring System

Applicant Agamatrix

K number K241304

NBW 2024-02-23

CONTOUR® PLUS BLUE Blood Glucose Monitoring System

Applicant Ascensia Diabetes Care

K number K231679

NBW 2024-01-19

RIGHTEST Blood Glucose Monitoring System Max Tel

Applicant Bionime Corporation

K number K231192

NBW 2023-12-22

VivaChek Link Plus Blood Glucose Monitoring System

Applicant Vivachek Biotech (Hangzhou) Co., Ltd.

K number K233058

NBW 2023-12-01

TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose Monitoring System

Applicant Sinocare, Inc.

K number K231476

NBW 2023-08-10

ReliOn Premier BLU Blood Glucose Monitoring System

Applicant I-Sens, Inc.

K number K230625

NBW 2023-08-10

Accu-Chek Guide Solo diabetes manager blood glucose monitoring system

Applicant Roche Diabetes Care GmbH

K number K213131

NBW 2023-06-28

MIO Blood Glucose Monitoring System

Applicant Mio Labs, Inc.

K number K223722

NBW 2022-12-21

GlucoSure ADVANCE Link Blood Glucose Monitoring System

K number K222234

NBW 2022-11-18

CONTOUR® NEXT GEN Blood Glucose Monitoring System

Applicant Ascensia Diabetes Care U.S., Inc.

K number K223293

NBW 2022-11-04

BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System

K number K220421

NBW 2022-10-07

SuperCheck Pro Blood Glucose Monitoring System

Applicant Ok Biotech Co., Ltd.

K number K213061

NBW 2022-08-29

GlucoLeader Enhance 2 Blood Glucose Monitoring System

Applicant Hmd Biomedical, Inc.

K number K212248

NBW 2022-08-25

GlucoSure Link Blood Glucose Monitoring System

K number K212140

NBW 2022-08-12

Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System

Applicant Bioland Technology, Ltd.

K number K202739

NBW 2022-06-16

FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System

K number K201037

NBW 2022-05-06

IWL2020 Blood Glucose Monitoring System

Applicant Roche Diabetes Care, Inc.

K number K203711

NBW 2022-04-06

MTM301 Blood Glucose and Ketone Monitoring System

K number K202534

NBW 2022-03-29

GAL-1A Plus Blood Glucose Monitoring System

K number K213887

NBW 2022-02-26

CardioChek Plus Test System; CardioChek Plus Home Test System

Applicant Polymer Technology Systems, Inc. D/B/A Pts Diagnostics

K number K193406

NBW 2021-12-23

Contour® next GEN Blood Glucose Monitoring System

Applicant Ascensia Diabetes Care

K number K193407

NBW 2021-10-15

MultiSure GK Link Blood Glucose and Ketone Monitoring System

K number K201880

NBW 2021-10-05

CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System

Applicant I-Sens, Inc.

K number K201394

NBW 2021-09-15

GlucoSure HT Plus Blood Glucose Monitoring System

K number K202885

NBW 2021-09-01

EASYMAX Tag Self-Monitoring Blood Glucose System

Applicant Eps Bio Technology Corp.

K number K201258

NBW 2021-08-11

CONTOUR® NEXT ONE Blood Glucose Monitoring System

Applicant Ascensia Diabetes Care

K number K210687

NBW 2021-07-13

Finetest Lite Blood Glucose Monitoring System

Applicant Osang Healthcare Co. , Ltd.

K number K203562

NBW 2020-10-16

Finetest Lite Smart Blood Glucose Monitoring System

Applicant Osang Healthcare Co. , Ltd.

K number K201396

NBW 2020-09-11

GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System

Applicant Microtech Medical, Inc.

K number K193340

NBW 2020-06-04

Livongo Blood Glucose Monitoring System (BG1000)

Applicant Livongo Health, Inc.

K number K200277

NBW 2020-03-20

Bioland Blood Glucose Monitoring System

Applicant Bioland Technology, Ltd.

K number K191657

NBW 2020-02-14

OneTouch Verio Reflect Blood Glucose Monitoring System

Applicant Lifescan Europe GmbH

K number K193475

NBW 2020-01-24

CareSens S Clear BT Blood Glucose Monitoring System

Applicant I-Sens, Inc.

K number K192859

NBW 2020-01-17

CareSens S Fit BT Blood Glucose Monitoring System

Applicant I-Sens, Inc.

K number K193590

NBW 2019-12-13

ReliOn Premier Classic Blood Glucose Monitoring System

Applicant I-Sens, Inc.

K number K192220

NBW 2019-11-08

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

Applicant Ascensia Diabetes Care

K number K191286

NBW 2019-11-01

MDT2 BLE Self-Monitoring Blood Glucose System

Applicant Eps Bio Technology Corp.

K number K190189

NBW 2019-10-17

On Call Express II Blood Glucose Monitoring System

Applicant ACON Laboratories, Inc.

K number K192175

NBW 2019-06-12

On Call Express Voice Blood Glucose Monitoring System

Applicant ACON Laboratories, Inc.

K number K191038

NBW 2019-06-04

TD-4183 Blood Glucose Monitoring System

K number K190579

NBW 2019-06-02

Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB

Applicant Bionime Corporation

K number K190564

NBW 2019-05-08

GlucoLeader Enhance Blood Glucose Monitoring System

Applicant Hmd Biomedical, Inc.

K number K182428

NBW 2019-04-10

GLUCOCARD® W onyx Blood Glucose Monitoring System

Applicant Arkray Factory, Inc.

K number K183306

NBW 2019-02-01

iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)

Applicant Andon Health Co, Ltd.

K number K181070

NBW 2018-12-19

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

Applicant Vivachek Laboratories, Inc.

K number K173140

NBW 2018-12-13

Accu-Chek Guide Me Blood Glucose Monitoring System

Applicant Roche Diabetes Care

K number K181131

NBW 2018-11-30

Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System

Applicant Tyson Bioresearch, Inc.

K number K182046

NBW 2018-11-30

POPS! one Blood Glucose Monitoring System

K number K181588

NBW 2018-11-29

Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System

Applicant Tyson Bioresearch, Inc.

K number K182047

NBW 2018-11-28

BGM014 Blood Glucose Monitoring System

K number K182992

NBW 2018-11-01

GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System

Applicant I-Sens, Inc.

K number K181273

NBW 2018-10-03

On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System

Applicant ACON Laboratories, Inc.

K number K181527

NBW 2018-09-19

Oh'Care Lite Smart Blood Glucose Monitoring System

Applicant Osang Healthcare Co. , Ltd.

K number K182286

NBW 2018-08-31

CareSens S Fit Blood Glucose Monitoring System

Applicant I-Sens, Inc.

K number K180866

NBW 2018-08-24

EasyMax BT Self-Monitoring Blood Glucose System

Applicant Eps Bio Technology Corp.

K number K182057

NBW 2018-08-21

Confidence Blood Glucose Monitoring System

Applicant Applied Biomedical, LLC

K number K173658

NBW 2018-08-17

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

Applicant Bionime Corporation

K number K173638

NBW 2018-08-09

FORA GTel Blood Glucose Monitoring System

Applicant Foracare, Inc.

K number K173505

NBW 2018-07-12

ActiveCare TD-4121 Blood Glucose Monitoring System

K number K173511

NBW 2018-06-19

Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus

Applicant Bionime Corporation

K number K173139

NBW 2018-06-14

POGO Automatic Blood Glucose Monitoring System

Applicant Intuity Medical, Inc.

K number K181316

NBW 2018-03-23

Dario LC Blood Glucose Monitoring System

Applicant Labstyle Innovation, Ltd.

K number K172723

NBW 2018-03-07

On Call Express Mobile Blood Glucose Monitoring System

Applicant ACON Laboratories, Inc.

K number K180196

NBW 2017-12-13

NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System

Applicant I-Sens, Inc.

K number K171480

NBW 2017-11-07

StatStrip Xpress Blood Glucose Monitoring System

Applicant Nova Biomedical Corporation

K number K170464

NBW 2017-11-02

PixoTest Blood Glucose Monitoring System

Applicant Ixensor Company , Ltd.

K number K163087

NBW 2017-10-19

CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System

Applicant I-Sens, Inc.

K number K170614

NBW 2017-10-17

SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System

Applicant Sd Biosensor

K number K160282

NBW 2017-10-13

GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring System

Applicant All Medicus Co., Ltd.

K number K170241

NBW 2017-10-06

Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System

Applicant Tyson Bioresearch, Inc.

K number K170079

NBW 2017-10-05

Gold AQ Blood Glucose Monitoring System

Applicant Changsha Sinocare, Inc.

K number K170264

NBW 2017-09-27

FreeStyle Precision Neo Blood Glucose Test Strips

Applicant Abbott Diabetes Care, Inc.

K number K171941

NBW 2017-09-20

NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352)

Applicant Biotest Medical Corporation

K number K171822

NBW 2017-09-15

WowGoHealth Blood Glucose Monitoring System

Applicant Biotest Medical Corporation

K number K171785

NBW 2017-09-15

iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5)

Applicant Andon Health Co, Ltd.

K number K170231

NBW 2017-08-16

GLUCOCARD W Blood Glucose Monitoring System

Applicant Arkray Factory, Inc.

K number K170064

NBW 2017-07-19

Dario Blood Glucose Monitoring System

Applicant Labstyle Innovations, Ltd.

K number K163159

NBW 2017-07-06

GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B,

Applicant Bionime Corporation

K number K170143

NBW 2017-06-07

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

Applicant Tianjin Empecs Medical Device Co., Ltd.

K number K162564

NBW 2017-05-02

iGlucose Blood Glucose Monitoring System

Applicant Bionime Corporation

K number K161790

NBW 2017-04-21

VivaChek Ino Blood Glucose Monitoring System

Applicant Vivachek Laboratories, Inc.

K number K160179

NBW 2017-04-14

Smart Dongle Blood Glucose Monitoring System

K number K162382

NBW 2017-04-06

POGO Automatic Blood Glucose Monitoring System

Applicant Intuity Medical, Inc.

K number K162203

NBW 2017-03-21

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

Applicant Tianjin Empecs Medical Device Co., Ltd.

K number K152534

NBW 2017-03-09

BGM009 Plus Blood Glucose Monitoring System

K number K170267

NBW 2017-02-16

AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System

Applicant Andon Health Co, Ltd.

K number K153561

NBW 2017-01-19

UniStrip1 Generic Blood Glucose Test Strips

Applicant Ok Biotech Co., Ltd.

K number K162430

NBW 2017-01-12

Contour Next EZ Blood Glucose Monitoring System

Applicant Ascensia Diabetes Care U.S., Inc.

K number K162336

NBW 2016-12-23

BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System

K number K161299

NBW 2016-12-16

NoCoding1 Plus Blood Glucose Monitoring System

Applicant I-Sens, Inc.

K number K160742

NBW 2016-11-30

One Drop Blood Glucose Monitoring System

Applicant Agamatrix, Inc.

K number K161834

NBW 2016-11-17

CONTOUR NEXT ONE Blood Glucose Monitoring System

Applicant Ascensia Diabetes Care

K number K160682