ClearanceBrief
Panels › Clinical Chemistry › Product code NBW · Class 2

System, Test, Blood Glucose, Over The Counter

Regulation 862.1345

5510(k)s in 12 months (513 all time)
4recalls in 12 months (137 all time)
100recalls that name a 510(k)
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Top companies in NBW

Company510(k)sRecalls
Taidoc Technology Corporation650
Abbott Diabetes Care1922
Lifescan, Inc.1317
Roche Diagnostics198
I-Sens, Inc.220
Apex BioTechnology Corp.180
Bionime Corporation180
Roche Diabetes Care413
Nova Biomedical Corp.610
EPS Bio Technology Corp.150
Decided510(k)Device and applicantCode
Oct 23, 2026K261293EASYMAX Voice Blood Glucose Monitoring System
EPS Bio Technology Corp., TW
NBW
Oct 9, 2026K260687VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring Syste
Vivachek Biotech (Hangzhou) Co., Ltd., CN
NBW
Oct 2, 2026K260689CVS Advanced PLUS Blood Glucose Monitoring System
I-Sens, Inc., KR
NBW
Aug 27, 2026K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ON
Ascensia Diabetes Care
NBW
Jul 23, 2026K262116TRUE METRIX Self Monitoring Blood Glucose System
Trividia Health, Inc.
NBW
Oct 10, 2025K250085On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring Syste
ACON Laboratories, Inc.
NBW
Jan 30, 2025K243060TeleRPM Gen2 Blood Glucose Monitoring System
Guangdong Transtek Medical Electronics Co., Ltd., CN
NBW
Nov 4, 2024K240637RIGHTEST Blood Glucose Monitoring System Max Tel
Bionime Corporation, TW
NBW
Oct 8, 2024K240640Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System
Sejoy Biomedical Co., Ltd., CN
NBW
Aug 27, 2024K241787CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System
Ascensia Diabetes Care U.S., Inc.
NBW
Aug 16, 2024K222126VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync B
Vivachek Biotech (Hangzhou) Co., Ltd., CN
NBW
Jun 6, 2024K241304WaveSense Jazz Blood Glucose Monitoring System
Agamatrix
NBW
Feb 23, 2024K231679CONTOUR® PLUS BLUE Blood Glucose Monitoring System
Ascensia Diabetes Care
NBW
Jan 19, 2024K231192RIGHTEST Blood Glucose Monitoring System Max Tel
Bionime Corporation, TW
NBW
Dec 22, 2023K233058VivaChek Link Plus Blood Glucose Monitoring System
Vivachek Biotech (Hangzhou) Co., Ltd., CN
NBW
Dec 1, 2023K231476TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose Monitoring System
Sinocare, Inc., CN
NBW
Aug 10, 2023K230625ReliOn Premier BLU Blood Glucose Monitoring System
I-Sens, Inc., KR
NBW
Aug 10, 2023K213131Accu-Chek Guide Solo diabetes manager blood glucose monitoring system
Roche Diabetes Care GmbH, DE
NBW
Jun 28, 2023K223722MIO Blood Glucose Monitoring System
Mio Labs, Inc.
NBW
Dec 21, 2022K222234GlucoSure ADVANCE Link Blood Glucose Monitoring System
Apex BioTechnology Corp., CN
NBW
Nov 18, 2022K223293CONTOUR® NEXT GEN Blood Glucose Monitoring System
Ascensia Diabetes Care U.S., Inc.
NBW
Nov 4, 2022K220421BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System
Apex BioTechnology Corp., CN
NBW
Oct 7, 2022K213061SuperCheck Pro Blood Glucose Monitoring System
Ok Biotech Co., Ltd., TW
NBW
Aug 29, 2022K212248GlucoLeader Enhance 2 Blood Glucose Monitoring System
Hmd Biomedical, Inc., TW
NBW
Aug 25, 2022K212140GlucoSure Link Blood Glucose Monitoring System
Apex BioTechnology Corp., TW
NBW
Aug 12, 2022K202739Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System
Bioland Technology, Ltd., CN
NBW
Jun 16, 2022K201037FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System
Taidoc Technology Corporation, TW
NBW
May 6, 2022K203711IWL2020 Blood Glucose Monitoring System
Roche Diabetes Care, Inc.
NBW
Apr 6, 2022K202534MTM301 Blood Glucose and Ketone Monitoring System
Apex BioTechnology Corp., TW
NBW
Mar 29, 2022K213887GAL-1A Plus Blood Glucose Monitoring System
Apex BioTechnology Corp., CN
NBW
Feb 26, 2022K193406CardioChek Plus Test System; CardioChek Plus Home Test System
Polymer Technology Systems, Inc. D/B/A Pts Diagnostics
NBW
Dec 23, 2021K193407Contour® next GEN Blood Glucose Monitoring System
Ascensia Diabetes Care
NBW
Oct 15, 2021K201880MultiSure GK Link Blood Glucose and Ketone Monitoring System
Apex BioTechnology Corp., TW
NBW
Oct 5, 2021K201394CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System
I-Sens, Inc., KR
NBW
Sep 15, 2021K202885GlucoSure HT Plus Blood Glucose Monitoring System
Apex BioTechnology Corp., CN
NBW
Sep 1, 2021K201258EASYMAX Tag Self-Monitoring Blood Glucose System
Eps Bio Technology Corp., TW
NBW
Aug 11, 2021K210687CONTOUR® NEXT ONE Blood Glucose Monitoring System
Ascensia Diabetes Care
NBW
Jul 13, 2021K203562Finetest Lite Blood Glucose Monitoring System
Osang Healthcare Co. , Ltd., KR
NBW
Oct 16, 2020K201396Finetest Lite Smart Blood Glucose Monitoring System
Osang Healthcare Co. , Ltd., KR
NBW
Sep 11, 2020K193340GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System
Microtech Medical, Inc.
NBW
Jun 4, 2020K200277Livongo Blood Glucose Monitoring System (BG1000)
Livongo Health, Inc.
NBW
Mar 20, 2020K191657Bioland Blood Glucose Monitoring System
Bioland Technology, Ltd., CN
NBW
Feb 14, 2020K193475OneTouch Verio Reflect Blood Glucose Monitoring System
Lifescan Europe GmbH, CH
NBW
Jan 24, 2020K192859CareSens S Clear BT Blood Glucose Monitoring System
I-Sens, Inc., KR
NBW
Jan 17, 2020K193590CareSens S Fit BT Blood Glucose Monitoring System
I-Sens, Inc., KR
NBW
Dec 13, 2019K192220ReliOn Premier Classic Blood Glucose Monitoring System
I-Sens, Inc., KR
NBW
Nov 8, 2019K191286CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Bloo
Ascensia Diabetes Care
NBW
Nov 1, 2019K190189MDT2 BLE Self-Monitoring Blood Glucose System
Eps Bio Technology Corp., TW
NBW
Oct 17, 2019K192175On Call Express II Blood Glucose Monitoring System
ACON Laboratories, Inc.
NBW
Jun 12, 2019K191038On Call Express Voice Blood Glucose Monitoring System
ACON Laboratories, Inc.
NBW

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