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) |
|---|---|---|---|
| Dec 8, 2006 | Medishop USA OneTouch/Basic/Profile Blood Glucose Test Strips, 50 Test Strips per box. Part Number 020-848, LIFESCAN, a Johnson & Johnson company. (The product is labeled in English, Greek and Portuguese) Terminated |
NBW | None listed |
| Aug 3, 2006 | Abbott Diabetes Care, Inc. Abbott brand FreeStyle Flash Blood Glucose Meter, distributed by Abbott Diabetes Care, 1420 Harbor Bay Pwky.
Alameda, CA 94502. Manufactured by:
Flextronics International, Long Jing Industrial Estate Terminated |
NBW | K051839 K992684 |
| Aug 3, 2006 | Abbott Diabetes Care, Inc. Abbott brand FreeStyle Blood Glucose Meter, distributed by Abbott Diabetes Care, 1420 Harbor Bay Pwky.
Alameda, CA 94502.
Manufactured by: Flextronics International, Long Jing Industrial Estate, Lon Terminated |
NBW | None listed |
| Mar 15, 2006 | Abbott Diabetes Care, Inc. FreeStyle Connect Point of Care Blood Glucose Monitoring System, including Control Solutions and Test Strips;
Part Number: 70672-01;
Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 Sou Terminated |
NBW | K051802 |
| Feb 25, 2006 | Becton Dickinson & Company Paradigm Link -- Blood Glucose Monitor. Terminated |
NBW | K041478 |
| Feb 25, 2006 | Becton Dickinson & Company BD Latitude (DMS) -- Blood Glucose Monitor. Terminated |
NBW | K022580 |
| Feb 25, 2006 | Becton Dickinson & Company BD Logic -- Blood Glucose Monitor. Terminated |
NBW | K041478 |
| Dec 8, 2005 | Lifescan Inc LifeScan brand OneTouch Ultra Test strips, 25 strips per vial Terminated |
NBW | K043197 |
| Dec 8, 2005 | Lifescan Inc LifeScan OneTouch Ultra Primary Care Physician Demo Kits, Blood Glucose Meter Terminated |
NBW | K043197 |
| Dec 8, 2005 | Lifescan Inc LifeScan OneTouch SureSoft Lancing Device, single use lancing device. Terminated |
NBW | None listed |
| Oct 21, 2005 | Abbott Laboratories Medisense Products FreeStyle Blood Glucose Monitoring System;
Recalling Firm/Manufacturer:
Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502 Terminated |
NBW | None listed |
| Oct 21, 2005 | Abbott Laboratories Medisense Products SofTrac Glucose Monitoring System;
Recalling Firm/Manufacturer:
Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502 Terminated |
NBW | None listed |
| Oct 21, 2005 | Abbott Laboratories Medisense Products Easy Glucose Monitoring System;
Recalling Firm/Manufacturer
Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502 Terminated |
NBW | None listed |
| Oct 21, 2005 | Abbott Laboratories Medisense Products Xtra Classic Glucose Monitoring System;
Recalling Firm/Manufacturer:
Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502 Terminated |
NBW | None listed |
| Oct 21, 2005 | Abbott Laboratories Medisense Products Optium Glucose Monitoring System;
Recalling Firm/Manufacturer:
Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502 Terminated |
NBW | None listed |
| Oct 21, 2005 | Abbott Laboratories Medisense Products Boots Glucose Monitoring System
Recalling Firm/Manufacturer:
Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502 Terminated |
NBW | None listed |
| Oct 21, 2005 | Abbott Laboratories Medisense Products Liberty Glucose Monitoring System;
Recalling Firm/Manufacturer:
Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502 Terminated |
NBW | None listed |
| Oct 21, 2005 | Abbott Laboratories Medisense Products RiteAid Glucose Monitoring System;
Recalling Firm/Manufacturer:
Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502 Terminated |
NBW | None listed |
| Oct 21, 2005 | Abbott Laboratories Medisense Products Kroger Glucose Monitoring System;
Recalling Firm/Manufacturer:
Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502 Terminated |
NBW | None listed |
| Oct 21, 2005 | Abbott Laboratories Medisense Products ReliOn Ultima Glucose Monitoring System;
Recalling Firm/Manufacturer:
Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502 Terminated |
NBW | None listed |
| Oct 21, 2005 | Abbott Laboratories Medisense Products Xceed Blood Glucose Monitoring System;
Recalling Firm/Manufacturer:
Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502 Terminated |
NBW | None listed |
| Oct 21, 2005 | Abbott Laboratories Medisense Products Tracker Blood Glucose Monitoring System;
Recalling Firm/Manufacturer:
Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502 Terminated |
NBW | None listed |
| Oct 21, 2005 | Abbott Laboratories Medisense Products FreeStyle FLASH Blood Glucose Monitoring System;
Recalling Firm/Manufacturer:
Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502 Terminated |
NBW | None listed |
| Sep 29, 2005 | Lifescan Inc LifeScan brand OneTouch Ultra Meter - Owner''s Booklet;
Product is manufactured and distributed by LifeScan, Inc., 1000 Gibraltar Dr., Milpitas, CA 95037 Terminated |
NBW | K024194 |
| Aug 13, 2005 | Roche Diagnostics Corp. ACCU-CHEK Go Care Kit; Catalog number 04470052001. Kit includes an ACCU-CHEK Go meter. Terminated |
NBW | K040796 |
| Jul 13, 2005 | Lifescan Inc LifeScan brand One Touch UltraSmart Meter Owners Booklet AW 060-788-01A;
All One Touch UltraSmart Meters shipped with OneTouch UltraSmart Owner''s Booklet AW 060-788-01A are affected by this Field Co Terminated |
NBW | K021819 |
| Jul 12, 2005 | Roche Diagnostics Corp. ACCU-CHEK Compact Care Kit; catalog number 3149137. Terminated |
NBW | K022171 |
| Jul 12, 2005 | Roche Diagnostics Corp. ACCU-CHEK Compact Meter; catalog number 3183572. Terminated |
NBW | K022171 |
| May 17, 2005 | Lifescan Inc LifeScan Brand InDuo Blood Glucose Meter Terminated |
NBW | K024194 |
| May 17, 2005 | Lifescan Inc LifeScan brand OneTouch FastTake Blood Glucose Meter Terminated |
NBW | K024194 |
| May 17, 2005 | Lifescan Inc LifeScan brand OneTouch Ultra Blood Glucose Meter Terminated |
NBW | K024194 |
| Dec 28, 2004 | Roche Diagnostics Corp. ACCU-CHEK Inform meter; catalog No. 3035123. Terminated |
NBW | K012210 |
| Jul 20, 2004 | Roche Diagnostics Corp. ACCU-CHEK Inform base unit; catalog no. 3035131. Terminated |
NBW | K003846 K012210 |
| Jul 20, 2004 | Roche Diagnostics Corp. ACCU-CHEK Inform meter; catalog No. 3035123. Terminated |
NBW | K003846 K012210 |
| Jul 20, 2004 | Becton Dickinson & Company The BD Blood Glucose Monitoring Systems identified as the BD Latitude, and BD Logic. Becton Dickinson also distributes the Paradigm Link Blood glucose Monitor which is sold exclusively for Medtronic Terminated |
NBW | None listed |
| Jul 20, 2004 | Becton Dickinson & Company BD Test Strips.
The US market BD Test Strips are identified by Catalog Numbers 322027 (50 count BD Test Strips Durable medical Equipment consignees), 322053 (50 Count BD Test Strips Trade consigne Terminated |
NBW | K022580 K022581 +1 |
| Sep 11, 2003 | Becton Dickinson & Company BD Blood Glucose Test strips. BD Latitude, 100 Test Strips 100 Bandelettes Reactives, Manufactured for BD by Nova Biomedical Corp, Waltham, MA 02454, Distributed by Becton Dickinson Canada, Inc., Oak Terminated |
NBW | K022580 K022581 |
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