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)
Get daily alerts for NBWSample briefCSV

Top companies in NBW

DateFirm and productCodeLinked 510(k)
Mar 12, 2026Trividia 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
NBWK143548
Mar 12, 2026Trividia 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
NBWK150052
Mar 12, 2026Trividia 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
NBWK140100
Mar 12, 2026Trividia 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
NBWK140100
Oct 30, 2025Trividia Health, Inc.
Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01.
Open, Classified
NBWK140100
Mar 5, 2025Telcare, LLC
Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009;
Open, Classified
NBWK110571
Jun 21, 2024Roche 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
NBWK160944
Jul 20, 2023Ascensia Diabetes Care US, Inc.
Contour next GEN Blood Glucose Monitoring System
Open, Classified
NBWK193407
Jun 21, 2022Touch US Llc
etouchus, model no. ETM-G01. Noninvasive Blood glucose meter.
Open, Classified
NBWNone listed
Jul 28, 2021Roche Diabetes Care, Inc.
Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001
Open, Classified
NBWK121679
Mar 16, 2021Cardinal Health Inc.
ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862
Open, Classified
NBWK113137
Mar 16, 2021Cardinal Health Inc.
ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443
Open, Classified
NBWK062195
Mar 16, 2021Cardinal Health Inc.
ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174
Open, Classified
NBWK062195
Apr 20, 2020Trividia 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
NBWK150052
Feb 28, 2020Abbott Diabetes Care, Inc.
Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653
Terminated
NBWK081975
Feb 28, 2020Abbott Diabetes Care, Inc.
Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023, 00093815988144
Terminated
NBWK040814
Dec 30, 2019Roche 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
NBWNone listed
Dec 30, 2019Roche 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
NBWNone listed
Dec 30, 2019Roche 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
NBWNone listed
Dec 30, 2019Roche 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
NBWNone listed
Dec 30, 2019Roche 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
NBWNone listed
Dec 30, 2019Roche 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
NBWK160944
Dec 11, 2019Roche Diabetes Care, Inc.
ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System Catalog Number: 06453970020
Terminated
NBWNone listed
Dec 11, 2019Roche Diabetes Care, Inc.
Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Catalog Number: 06908217001
Terminated
NBWK131029
Dec 11, 2019Roche Diabetes Care, Inc.
Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog Number: 06908349001
Terminated
NBWK131029
Dec 2, 2019Polymer Technology Systems, Inc.
Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number 4060 HS, 570-0411
Terminated
NBWK140068
Dec 2, 2019Polymer Technology Systems, Inc.
Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036
Terminated
NBWK140068
Dec 2, 2019Polymer Technology Systems, Inc.
PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, without box or carrying case, Reference Numbers 2702
Terminated
NBWK140068
Dec 2, 2019Polymer Technology Systems, Inc.
PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference Numbers 2700
Terminated
NBWK140068
Sep 30, 2019Roche 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
NBWK133862
Sep 30, 2019Roche 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
NBWK133862
Aug 29, 2019LABSTYLE INNOVATIONS
Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2
Terminated
NBWK150817
Jul 26, 2018Cambridge Sensors Limited
Microdot Xtra blood glucose test strips
Open, Classified
NBWK083273
Mar 14, 2018Polymer Technology Systems, Inc.
PTS Panels CHOL+GLU Test Strips (REF 1765)
Terminated
NBWK041750
Jun 28, 2016Trividia 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
NBWK090495
Jun 28, 2016Trividia 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
NBWK042080
Jun 28, 2016Trividia 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
NBWK030703
K032657
Jun 28, 2016Trividia 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
NBWK080641
K080710
Apr 29, 2016Livongo 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
NBWK133584
Mar 15, 2016Polymer Technology Systems, Inc.
PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers
Terminated
NBWK071507
K162282
Dec 23, 2014Unistrip 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
NBWNone listed
May 13, 2014Roche 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
NBWK113614
Mar 18, 2014Abbott 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
NBWK092638
Mar 18, 2014Abbott 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
NBWK092638
Feb 3, 2014Nipro 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
NBWK032657
Feb 3, 2014Nipro 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
NBWK090495
Dec 17, 2013Abbott 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
NBWK092602
Dec 17, 2013Abbott 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
NBWK092602
Nov 22, 2013Roche 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
NBWK111353
Aug 9, 2013Nova 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
NBWK091547

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.