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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

DateFirm and productCodeLinked 510(k)
Aug 9, 2013Nova 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
NBWK091547
Aug 9, 2013Nova 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
NBWK091547
Aug 9, 2013Nova 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
NBWK091547
Aug 9, 2013Nova 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
NBWK091547
Aug 9, 2013Nova 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
NBWK091547
Aug 9, 2013Nova 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
NBWK091547
Aug 9, 2013Nova 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
NBWK091547
Aug 9, 2013Nova 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
NBWK091547
Aug 9, 2013Nova 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
NBWK091547
May 25, 2013Polymer 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
NBWK013068
May 9, 2013Abbott 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
NBWK120568
Apr 18, 2013Nipro 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
NBWK030703
K032657
Apr 15, 2013Roche 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
NBWK121679
Apr 12, 2013Lifescan 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
NBWNone listed
Apr 9, 2012Roche 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
NBWK113137
Jun 21, 2011Roche Diagnostics Operations, Inc.
ACCU-CHECK PERFORMA STRIP NO. 05987288031, 100 BANDELETTES REACTIVES, ROCHE DIAGNOSTICS GMBH, WWW.ACCUCHEK.COM glucose monitoring test strips.
Terminated
NBWNone listed
Feb 15, 2011Abbott 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
NBWK051839
Feb 9, 2011Abbott Diabetes Care, Inc.
Abbott Diabetes Care, ReliOn Ultima Blood Glucose Test ;
Terminated
NBWK083223
Feb 9, 2011Abbott 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
NBWK051213
Feb 9, 2011Abbott Diabetes Care, Inc.
Abbott Diabetes Care, Precision Point of Care Blood Glucose Test Strips;
Terminated
NBWK070984
Feb 9, 2011Abbott Diabetes Care, Inc.
Abbott Diabetes Care, Optium Blood Glucose Test Strips;
Terminated
NBWK051213
Feb 9, 2011Abbott Diabetes Care, Inc.
Abbott Diabetes Care, MediSense Optium Blood Glucose Test Strips; MediSense Optium Blood Glucose Electrodes;
Terminated
NBWK051213
Feb 9, 2011Abbott Diabetes Care, Inc.
Abbott Diabetes Care Optium EZ Blood Glucose Test Strips;
Terminated
NBWK081975
Feb 9, 2011Abbott Diabetes Care, Inc.
Abbott Diabetes Care Precision Xceed Pro Blood Glucose Test Strips
Terminated
NBWK070984
Oct 1, 2010Lifescan Inc
One Touch Ultra Test Strips, Part Number 020-245-32, lot number 2964512, Manufactured by LifeScan Inc., Milpitas, CA.
Terminated
NBWK062195
Sep 30, 2010Polymer 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
NBWK071507
Jul 17, 2010Lifescan 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
NBWK023194
Jul 17, 2010Lifescan 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
NBWK022724
Sep 16, 2009Roche 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
NBWK070585
Sep 16, 2009Roche 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
NBWK070585
Sep 10, 2009Oak 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
NBWK083099
Sep 1, 2009Abbott 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
NBWK070850
Mar 17, 2009Lifescan 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
NBWK022724
Nov 21, 2008Lifescan 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
NBWK062195
Apr 8, 2008Lifescan 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
NBWK984527
Feb 16, 2008Invictus Scientific Inc
Invictus-- Bionime Rightest Blood Glucose Monitoring System MODEL: GM300; Invictus Scientific, Inc., San Diego, CA
Terminated
NBWK042678
K053635 +1
Feb 14, 2008Abbott 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
NBWK033845
K040814
Jul 13, 2007Lifescan 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
NBWK062195
Jun 7, 2007Abbott Diabetes Care, Inc.
Precision Xtra Blood Glucose monitoring system. Individual test meter and test strip kit.
Terminated
NBWK033845
K040814
May 23, 2007Abbott 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
NBWNone listed
Apr 7, 2007Smith & Nephew, Inc. Endoscopy Division
Smith & Nephew Suture Passer 2 inch Part Number : 7209167
Terminated
NBWNone listed
Apr 7, 2007Smith & Nephew, Inc. Endoscopy Division
Smith & Nephew Suture Passer 12 inch Part Number 7209166D (refurbished)
Terminated
NBWNone listed
Apr 7, 2007Smith & Nephew, Inc. Endoscopy Division
Smith & Nephew Suture Passer 12 inch Part Number: 7209166
Terminated
NBWNone listed
Mar 3, 2007Safety & Supplies Co. Inc.
One Touch Basic/Profile and One Touch Ultra-Blood Glucose Test strips- 50-count
Terminated
NBWNone listed
Feb 14, 2007Matrix Distributors, Inc.
One Touch Ultra Blood Glucose Test Strips-Lot # 2691191, LifeScan
Terminated
NBWNone listed
Jan 5, 2007Core Care Technologies, Inc
One Touch Basic/Profile and One Touch Ultra Blood Glucose Test Strips
Terminated
NBWNone listed
Jan 5, 2007Lifescan 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
NBWK022724
Jan 5, 2007Discount Diabetic Supply
One Touch Ultra Blood Glucose test strips, LifeScan, a Johnson & Johnson Co., 50 test strips, 2 vials of 25 test strips
Terminated
NBWNone listed
Dec 29, 2006Royal Global Wholesale
OneTouch Ultra- Blood Glucose test strips. For use with One Touch Brand Meters blood glucose meters
Terminated
NBWNone listed
Dec 16, 2006Medical Plastics Devices Inc
One Touch Basic/Profile Blood Glucose test strips
Terminated
NBWNone listed

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