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)
Top companies in NBW
| Company | 510(k)s | Recalls |
|---|---|---|
| Taidoc Technology Corporation | 65 | 0 |
| Abbott Diabetes Care | 19 | 22 |
| Lifescan, Inc. | 13 | 17 |
| Roche Diagnostics | 19 | 8 |
| I-Sens, Inc. | 22 | 0 |
| Apex BioTechnology Corp. | 18 | 0 |
| Bionime Corporation | 18 | 0 |
| Roche Diabetes Care | 4 | 13 |
| Nova Biomedical Corp. | 6 | 10 |
| EPS Bio Technology Corp. | 15 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 12, 2026 | Trividia Health, Inc. Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item:
Walgreens TRUE METRIX GO Kit/RF4001-01BK,
CVS TRUE METRIX GO Kit/RF4007-0 Open, Classified |
NBW | K143548 |
| Mar 12, 2026 | Trividia Health, Inc. Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item:
Walgreens TRUE METRIX AIR Kit/REA4001-01,
Leader TRUE METRIX AIR Kit/REA4 Open, Classified |
NBW | K150052 |
| Mar 12, 2026 | Trividia Health, Inc. Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Description/Item:
TRUE METRIX PRO Meter Only/RE4H01P-40,
TRUE METRIX PRO Starter Kit/RE4H Open, Classified |
NBW | K140100 |
| Mar 12, 2026 | Trividia Health, Inc. Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item:
Walgreens TRUE METRIX Kit/RE4001-01,
Leader TRUE METRIX Kit/RE4002-01,
L Open, Classified |
NBW | K140100 |
| Oct 30, 2025 | Trividia Health, Inc. Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01. Open, Classified |
NBW | K140100 |
| Mar 5, 2025 | Telcare, LLC Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009; Open, Classified |
NBW | K110571 |
| Jun 21, 2024 | Roche Diabetes Care, Inc. Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control Open, Classified |
NBW | K160944 |
| Jul 20, 2023 | Ascensia Diabetes Care US, Inc. Contour next GEN Blood Glucose Monitoring System Open, Classified |
NBW | K193407 |
| Jun 21, 2022 | Touch US Llc etouchus, model no. ETM-G01. Noninvasive Blood glucose meter. Open, Classified |
NBW | None listed |
| Jul 28, 2021 | Roche Diabetes Care, Inc. Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001 Open, Classified |
NBW | K121679 |
| Mar 16, 2021 | Cardinal Health Inc. ACCU-CHEK SMARTVIEW 100 TEST STRIPS
Item Number: 4742862 Open, Classified |
NBW | K113137 |
| Mar 16, 2021 | Cardinal Health Inc. ONETOUCH ULTRA TEST STRIPS 25 COUNT
Item Number: 3510443 Open, Classified |
NBW | K062195 |
| Mar 16, 2021 | Cardinal Health Inc. ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT
Item Number: 2990174 Open, Classified |
NBW | K062195 |
| Apr 20, 2020 | Trividia Health, Inc. TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM - Product Usage: is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or for Terminated |
NBW | K150052 |
| Feb 28, 2020 | Abbott Diabetes Care, Inc. Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653 Terminated |
NBW | K081975 |
| Feb 28, 2020 | Abbott Diabetes Care, Inc. Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023, 00093815988144 Terminated |
NBW | K040814 |
| Dec 30, 2019 | Roche Diabetes Care, Inc. Blood Glucose Monitoring System, Model Number 08313202001
ACCU CHEK GUIDE HCP SAMPLE LAUNCH BOX - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measu Terminated |
NBW | None listed |
| Dec 30, 2019 | Roche Diabetes Care, Inc. Blood Glucose Monitoring System, Model Number 08453063001
ACCU-CHEK GUIDE SAMPLE KIT FCN MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively mea Terminated |
NBW | None listed |
| Dec 30, 2019 | Roche Diabetes Care, Inc. Blood Glucose Monitoring System, Model Number 08453071001
ACCU-CHEK GUIDE RETAIL KIT FCN MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively mea Terminated |
NBW | None listed |
| Dec 30, 2019 | Roche Diabetes Care, Inc. Blood Glucose Monitoring System, Model Number 07400942001
ACCU-CHEK GUIDE METER ONLY MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure Terminated |
NBW | None listed |
| Dec 30, 2019 | Roche Diabetes Care, Inc. Blood Glucose Monitoring System, Model Number 07400926001
ACCU-CHEK GUIDE RETAIL KIT MG/DL - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure gl Terminated |
NBW | None listed |
| Dec 30, 2019 | Roche Diabetes Care, Inc. Blood Glucose Monitoring System, Model Number 07400870001
ACCU-CHEK GUIDE SAMPLE KIT MG/DL - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure gl Terminated |
NBW | K160944 |
| Dec 11, 2019 | Roche Diabetes Care, Inc. ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System
Catalog Number: 06453970020 Terminated |
NBW | None listed |
| Dec 11, 2019 | Roche Diabetes Care, Inc. Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System
Catalog Number: 06908217001 Terminated |
NBW | K131029 |
| Dec 11, 2019 | Roche Diabetes Care, Inc. Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System
Catalog Number: 06908349001 Terminated |
NBW | K131029 |
| Dec 2, 2019 | Polymer Technology Systems, Inc. Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number 4060 HS, 570-0411 Terminated |
NBW | K140068 |
| Dec 2, 2019 | Polymer Technology Systems, Inc. Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036 Terminated |
NBW | K140068 |
| Dec 2, 2019 | Polymer Technology Systems, Inc. PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, without box or carrying case, Reference Numbers 2702 Terminated |
NBW | K140068 |
| Dec 2, 2019 | Polymer Technology Systems, Inc. PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference Numbers 2700 Terminated |
NBW | K140068 |
| Sep 30, 2019 | Roche Diabetes Care, Inc. Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary w Terminated |
NBW | K133862 |
| Sep 30, 2019 | Roche Diabetes Care, Inc. Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whol Terminated |
NBW | K133862 |
| Aug 29, 2019 | LABSTYLE INNOVATIONS Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2 Terminated |
NBW | K150817 |
| Jul 26, 2018 | Cambridge Sensors Limited Microdot Xtra blood glucose test strips Open, Classified |
NBW | K083273 |
| Mar 14, 2018 | Polymer Technology Systems, Inc. PTS Panels CHOL+GLU Test Strips (REF 1765) Terminated |
NBW | K041750 |
| Jun 28, 2016 | Trividia Health TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 Open, Classified |
NBW | K090495 |
| Jun 28, 2016 | Trividia Health TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 Open, Classified |
NBW | K042080 |
| Jun 28, 2016 | Trividia Health TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 Open, Classified |
NBW | K030703 K032657 |
| Jun 28, 2016 | Trividia Health TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 Open, Classified |
NBW | K080641 K080710 |
| Apr 29, 2016 | Livongo Health The Livongo Health In Touch Blood Glucose Monitoring System (BGMS), is an Over-The-Counter (OTC) system designed for the self- monitoring of blood glucose by persons with diabetes in home settings to Terminated |
NBW | K133584 |
| Mar 15, 2016 | Polymer Technology Systems, Inc. PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers Terminated |
NBW | K071507 K162282 |
| Dec 23, 2014 | Unistrip Technologies LLC UniStrip1, Blood Glucose Test Strips, 50 count box.
The test strips are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control. Terminated |
NBW | None listed |
| May 13, 2014 | Roche Diagnostics Operations, Inc. ACCU-CHEK Compact Plus Test Strips
For use with: ACCU-CHEK Compact Plus Meters; 17 count sample strip
51 count retail strip; 102 count retail strip; 51 count MedBen strip
51 count Mail Order strip; Sa Terminated |
NBW | K113614 |
| Mar 18, 2014 | Abbott Diabetes Care, Inc. FreeStyle Flash Blood Glucose Monitors System.
Meter made in China;
Distributed by TheraSense, Alameda, CA
The FreeStyle Flash meter should only be used with FreeStyle Test Strips and FreeStyle C Terminated |
NBW | K092638 |
| Mar 18, 2014 | Abbott Diabetes Care, Inc. FreeStyle Blood Glucose Monitors System.
For in vitro diagnostic use only. Store at room
temperature below 86 degrees F (30 degrees C). Use test strips
only within the system operating temperature
ran Terminated |
NBW | K092638 |
| Feb 3, 2014 | Nipro Diagnostics, Inc. MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEtrack. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 33309 U.S.A.
Is intend Terminated |
NBW | K032657 |
| Feb 3, 2014 | Nipro Diagnostics, Inc. MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEbalance. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 33309 U.S.A.
Is inte Terminated |
NBW | K090495 |
| Dec 17, 2013 | Abbott Diabetes Care, Inc. FreeStyle Lite Blood Glucose Test Strips;
For in vitro diagnostic testing.
50 count; 100 count Product of Ireland;
UPC 6 99073 70819 9; - 50 count
UPC 6 99073 70822 9 - 50 count
UPC 6 99073 71026 0 Terminated |
NBW | K092602 |
| Dec 17, 2013 | Abbott Diabetes Care, Inc. FreeStyle Blood Glucose Test Strips;
For in vitro diagnostic testing.
50 count
UPC 6 99073 12050 2;
Freestyle Blood Glucose Test Strips; for Institutional Use only
50 count:
UPC 6 99073 70792 5
Manu Terminated |
NBW | K092602 |
| Nov 22, 2013 | Roche Diagnostics Operations, Inc. ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo System)\
The ACCU-CHEK Combo System is indicated for the treatment of insulin-requiring diabetes and for the quantita Terminated |
NBW | K111353 |
| Aug 9, 2013 | Nova Biomedical Corporation Nova Max Plus Monitor System (Kit w/10 Count Vials International)
Catalog Number: 45507
Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Terminated |
NBW | K091547 |
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