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) |
|---|---|---|---|
| Aug 9, 2013 | Nova Biomedical Corporation Nova Max Plus Monitor System (Kit w/10 Count Vials Canada) Catalog Number: 43861
Product usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, N Terminated |
NBW | K091547 |
| Aug 9, 2013 | Nova Biomedical Corporation Nova Max Glucose Test Strips (10 Count Canada)Catalog Number: 43877
Product The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Ma Terminated |
NBW | K091547 |
| Aug 9, 2013 | Nova Biomedical Corporation Nova Max Plus Monitor System (Kit w/10 Count Vials)
Catalog Number: 43435
Product usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Terminated |
NBW | K091547 |
| Aug 9, 2013 | Nova Biomedical Corporation Nova Max Glucose Test Strips (50 Count International
Catalog Number: 45512
Product usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Ma Terminated |
NBW | K091547 |
| Aug 9, 2013 | Nova Biomedical Corporation Nova Max Glucose Test Strips (10 Count Vials)
Catalog Number: 43604
These strips are kitted into Nova Max Glucose Test Strip System Kits 43435 and 45507
Product Usage: The Nova Max Glucose Test Str Terminated |
NBW | K091547 |
| Aug 9, 2013 | Nova Biomedical Corporation Nova Max Glucose Test Strips (100 Count Retail Canada)Catalog Number: 43955
Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Terminated |
NBW | K091547 |
| Aug 9, 2013 | Nova Biomedical Corporation Nova Max Glucose Test Strips (10 Count Boxed)
Catalog Number: 43590
Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus Terminated |
NBW | K091547 |
| Aug 9, 2013 | Nova Biomedical Corporation Nova Max Glucose Test Strips (50 Count DME)
Catalog Number: 43523
Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Terminated |
NBW | K091547 |
| Aug 9, 2013 | Nova Biomedical Corporation Nova Max Glucose Test Strips (50 Count Retail)
Catalog Number: 43437
Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plu Terminated |
NBW | K091547 |
| May 25, 2013 | Polymer Technology Systems, Inc. PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers
Product Usage: used by healthcare professionals and individuals with diabetes to measure glucose in whole blood Terminated |
NBW | K013068 |
| May 9, 2013 | Abbott Diabetes Care, Inc. FreeStyle InsuLinx Blood Glucose Monitoring System:
For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips.
Abbott Diabetes Care, Inc.
1360 South Loop Road
Alameda, CA 94502 U Terminated |
NBW | K120568 |
| Apr 18, 2013 | Nipro Diagnostics, Inc. Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81
The TRUEtrack Blood Glucose System is intended for the quantitative determination of glucose in human whole blood taken from fi Terminated |
NBW | K030703 K032657 |
| Apr 15, 2013 | Roche Diagnostics Operations, Inc. ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner.
Used with the ACCU-CHEK Inform II System to quantitatively measure glucose (sugar). Terminated |
NBW | K121679 |
| Apr 12, 2013 | Lifescan Inc All OneTouch Verio IQ Blood Glucose Meters sold as:
Verio IQ System Kits - Meter;
Verio IQ Starter kits - Meter;
Verio IQ Warranty Meter.
Product Usage: The OneTouch VerioIQ Blood Glucose Monitorin Terminated |
NBW | None listed |
| Apr 9, 2012 | Roche Diagnostics Operations, Inc. ACCU-CHEK Aviva Nano Blood Glucose Meter
No product labeling, beyond the labels applied to the meter, was provided with the meter as these meters were never intended to be distributed. A representa Terminated |
NBW | K113137 |
| Jun 21, 2011 | Roche Diagnostics Operations, Inc. ACCU-CHECK PERFORMA STRIP NO. 05987288031, 100 BANDELETTES REACTIVES, ROCHE DIAGNOSTICS GMBH, WWW.ACCUCHEK.COM glucose monitoring test strips. Terminated |
NBW | None listed |
| Feb 15, 2011 | Abbott Diabetes Care, Inc. FreeStyle Blood Glucose Monitoring System Test Strips and Freestyle Lite Blood Glucose Monitoring System Test Strips, for use with FreeStyle and FreeStyle Lite Test Strips respectively, 100 count, man Terminated |
NBW | K051839 |
| Feb 9, 2011 | Abbott Diabetes Care, Inc. Abbott Diabetes Care, ReliOn Ultima Blood Glucose Test ; Terminated |
NBW | K083223 |
| Feb 9, 2011 | Abbott Diabetes Care, Inc. Abbott Diabetes Care, Precision Xtra Blood Glucose Test Strips;
Precision Xtra Blood Glucose & Ketone Monitoring System;
Precision G3b Smartblue Blood Glucose Test Strips; Terminated |
NBW | K051213 |
| Feb 9, 2011 | Abbott Diabetes Care, Inc. Abbott Diabetes Care, Precision Point of Care Blood Glucose Test Strips; Terminated |
NBW | K070984 |
| Feb 9, 2011 | Abbott Diabetes Care, Inc. Abbott Diabetes Care, Optium Blood Glucose Test Strips; Terminated |
NBW | K051213 |
| Feb 9, 2011 | Abbott Diabetes Care, Inc. Abbott Diabetes Care, MediSense Optium Blood Glucose Test Strips;
MediSense Optium Blood Glucose Electrodes; Terminated |
NBW | K051213 |
| Feb 9, 2011 | Abbott Diabetes Care, Inc. Abbott Diabetes Care Optium EZ Blood Glucose Test Strips; Terminated |
NBW | K081975 |
| Feb 9, 2011 | Abbott Diabetes Care, Inc. Abbott Diabetes Care Precision Xceed Pro Blood Glucose Test Strips Terminated |
NBW | K070984 |
| Oct 1, 2010 | Lifescan Inc One Touch Ultra Test Strips, Part Number 020-245-32, lot number 2964512, Manufactured by LifeScan Inc., Milpitas, CA. Terminated |
NBW | K062195 |
| Sep 30, 2010 | Polymer Technology Systems, Inc. PTS Panels Test Strips, CHOL +HDL+GLU Panel for CardioChek PA brand analyzers, 15 tests 1 MEMo Chip, manufacturer Polymer Technology Systems, Inc., 7736 Zionsville Rd., Indianapolis, IN 46268. Terminated |
NBW | K071507 |
| Jul 17, 2010 | Lifescan Inc OneTouch SureStep Pro Test strips, for use with the OneTouch SureStep Pro Blood Glucose Meters, in 50 count packaging distributed by LifeScan Inc., Milpitas, CA, Manufactured by LifeScan Puerto Rico
Terminated |
NBW | K023194 |
| Jul 17, 2010 | Lifescan Inc OneTouch SureStep and SureStep Pro Test strips, for use with the OneTouch SureStep Blood Glucose Meters, in 100 count and 50 count packaging distributed by LifeScan Inc., Milpitas, CA, Manufactured by Terminated |
NBW | K022724 |
| Sep 16, 2009 | Roche Diagnostics Corp. Roche ACCU-CHEK Performa blood glucose meters/kits, Roche Diagnostics, Indianapolis, IN.
Test strips for quantitative blood glucose measurements in fresh capillary, arterial, or neonatal blood, as Terminated |
NBW | K070585 |
| Sep 16, 2009 | Roche Diagnostics Corp. Roche ACCU-CHEK Performa blood glucose test strips, Roche Diagnostics, Indianapolis, IN.
Test strips for quantitative blood glucose measurements in fresh capillary, arterial, or neonatal blood, as Terminated |
NBW | K070585 |
| Sep 10, 2009 | Oak Tree International Holdings, LLC, Inc. EASYMax N. Self-Monitoring Blood Glucose System, distributed in cardboard carton kits. Each kit contains the following components: Blood Glucose Meter; Test Strip x 10 ct.; Normal Control Solution; Terminated |
NBW | K083099 |
| Sep 1, 2009 | Abbott Diabetes Care, Inc. FreeStyle Lite Blood Glucose Test Strips, CSP, 50's US, Checkpoint, FS Lite, for use with FreeStyle Lite Blood Glucose Meters and FreeStyle Freedom Lite Blood Glucose Meters, Part Number 70822-02, man Terminated |
NBW | K070850 |
| Mar 17, 2009 | Lifescan Inc OneTouch SureStep Test Strips, Part numbers 020-052-01 and 010-359-04, for use with SureStep brand Blood Glucose Meters, manufactured by LifeScan Inc., Milpitas, CA Terminated |
NBW | K022724 |
| Nov 21, 2008 | Lifescan Inc One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count.
Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Terminated |
NBW | K062195 |
| Apr 8, 2008 | Lifescan Inc LifeScan OneTouch Data Management Software Version 1.0, Part Number: 021-722-01(for OneTouch Select and UltraMini (Download) Blood Glucose Meters), LifeScan Inc, Milpitas, CA 95037. Terminated |
NBW | K984527 |
| Feb 16, 2008 | Invictus Scientific Inc Invictus-- Bionime Rightest Blood Glucose Monitoring System
MODEL: GM300; Invictus Scientific, Inc., San Diego, CA Terminated |
NBW | K042678 K053635 +1 |
| Feb 14, 2008 | Abbott Diabetes Care, Inc. Blood glucose meter, marketed with multiple brand names including: Precision Xtra New and Improved meter, Precision Xceed meter, Optium Xceed meter, Optium meter, ReliOn Ultima meter, Rite Aid meter, Terminated |
NBW | K033845 K040814 |
| Jul 13, 2007 | Lifescan Inc OneTouch Ultra Test strip, a component of the following OneTouch Ultra Glucose monitoring systems: a)OneTouch Ultra, b) OneTouch InDuo, c) OneTouch Ultra2, d) OneTouch UltraMini, e) OneTouch UltraSma Terminated |
NBW | K062195 |
| Jun 7, 2007 | Abbott Diabetes Care, Inc. Precision Xtra Blood Glucose monitoring system. Individual test meter and test strip kit. Terminated |
NBW | K033845 K040814 |
| May 23, 2007 | Abbott Diabetes Care, Inc. Abbott Precision Link Software (Version 2.1), (Version 2.2), (Version 2.3), (Version 2.4), (Version 2.5), and (Version 2.6); Serial Number(s): ALL; Terminated |
NBW | None listed |
| Apr 7, 2007 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew Suture Passer 2 inch
Part Number : 7209167 Terminated |
NBW | None listed |
| Apr 7, 2007 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew Suture Passer 12 inch
Part Number 7209166D (refurbished) Terminated |
NBW | None listed |
| Apr 7, 2007 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew Suture Passer 12 inch
Part Number: 7209166 Terminated |
NBW | None listed |
| Mar 3, 2007 | Safety & Supplies Co. Inc. One Touch Basic/Profile and One Touch Ultra-Blood Glucose Test strips- 50-count Terminated |
NBW | None listed |
| Feb 14, 2007 | Matrix Distributors, Inc. One Touch Ultra Blood Glucose Test Strips-Lot # 2691191, LifeScan Terminated |
NBW | None listed |
| Jan 5, 2007 | Core Care Technologies, Inc One Touch Basic/Profile and One Touch Ultra Blood Glucose Test Strips Terminated |
NBW | None listed |
| Jan 5, 2007 | Lifescan Inc LifeScan brand OneTouch Sure Step- Blood Glucose Monitoring System Test Strips, 50 strips per package,
Distributed and Manufactured by: LifeScan, Inc.,
1000 Gibraltar Drive, Milpitas, CA 95037 Terminated |
NBW | K022724 |
| Jan 5, 2007 | Discount Diabetic Supply One Touch Ultra Blood Glucose test strips, LifeScan, a Johnson & Johnson Co., 50 test strips, 2 vials of 25 test strips Terminated |
NBW | None listed |
| Dec 29, 2006 | Royal Global Wholesale OneTouch Ultra- Blood Glucose test strips. For use with One Touch Brand Meters blood glucose meters Terminated |
NBW | None listed |
| Dec 16, 2006 | Medical Plastics Devices Inc One Touch Basic/Profile Blood Glucose test strips Terminated |
NBW | None listed |
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