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Panels › Clinical Chemistry › Product code LFR · Class 2

Glucose Dehydrogenase, Glucose

Regulation 862.1345

0510(k)s in 12 months (73 all time)
0recalls in 12 months (51 all time)
43recalls that name a 510(k)
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Top companies in LFR

DateFirm and productCodeLinked 510(k)
Jul 28, 2021Roche Diabetes Care, Inc.
Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001
Open, Classified
LFRK113137
Jul 28, 2021Roche Diabetes Care, Inc.
Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001
Open, Classified
LFRK133741
May 9, 2018Roche Diabetes Care, Inc.
Accu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. 05942861001 Product Usage: The Accu-Chek Inform II test strips are for use with the Accu-Chek Inform II meter to quantitat
Terminated
LFRK131029
May 9, 2018Roche Diabetes Care, Inc.
Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 07299702001 Product Usage: The Accu-Chek Performa test strips are for use with the Accu-Chek Performa meter to quantitative
Terminated
LFRK131029
May 9, 2018Roche Diabetes Care, Inc.
Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268001, 06908349001,06908217001 Product Usage: The Accu-Chek Aviva Plus test strips are for use with t
Terminated
LFRK131029
Mar 14, 2016Roche Diagnostics Operations, Inc.
Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Glucose Monitoring System Accu-Chek inform II Blood Glucose Monitoring System is intended for testing outside the body (in vitr
Terminated
LFRK121679
Apr 2, 2012Lifescan Inc
OneTouch Verio IQ Blood Glucose Monitoring System Kit; One Touch Verio IQ Blood Glucose IQ Blood Glucose Monitoring Starter Kit; One Touch Verio IQ Blood Glucose Monitoring Warranty Kit. Distributed
Terminated
LFRK110637
Sep 19, 2011Bayer Healthcare, LLC
Contour, Contour TS Blood Glucose Test Strips and Bonus Packs Intended for self-testing by people with diabetes and healthcare professionals to monitor glucose concentrations in whole blood
Terminated
LFRK062058
Aug 11, 2009Roche Diagnostics Corp.
Roche ACCU-CHEK Compact Plus Meter Kit, Roche Diagnostics, Indianapolis, IN; REFS 03149137001, 05177294001 and 05079241001 include the Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Dia
Terminated
LFRK040796
Aug 11, 2009Roche Diagnostics Corp.
Roche ACCU-Chek Aviva Meter Kit, Roche Diagnostics, Indianapolis, IN; REF 04893247001 includes the Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Model 3
Terminated
LFRK060620
Aug 11, 2009Roche Diagnostics Corp.
Roche ACCU-Chek Voicemate Meter, Roche Diagnostics, Indianapolis, IN; REF 12030802001 includes the Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Model 3
Terminated
LFRK982079
Aug 11, 2009Roche Diagnostics Corp.
Roche ACCU-Chek Active Meter Kit, Roche Diagnostics, Indianapolis, IN; REF 03184501001 includes the Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Model
Terminated
LFRK021827
Sep 11, 2008Abbott Diabetes Care, Inc.
Abbott FreeStyle Blood Glucose Monitoring System Test Strips for use with FreeStyle Blood Glucose Monitoring Meter
Terminated
LFRK992684
Mar 13, 2008Bayer Healthcare LLC
Bayer Contour TS blood glucose test strips packaged in packs of 10, 25, 50 and 100 strips; Bayer Healthcare, Mishawaka, IN. U.S. Product codes 1820, 1823, 1825 and 9578; 1835 and 1836 (Korea); 1832,
Terminated
LFRNone listed
Mar 13, 2008Bayer Healthcare LLC
Bayer Contour TS blood glucose monitoring system with 10 blood glucose test strips enclosed; Bayer Healthcare, Mishawaka, IN. Products 1802 and 1802N (U.S.), 1810 (Korea), 1811 (India, Korea and Mexi
Terminated
LFRNone listed
Jul 3, 2007Bayer Healthcare LLC
Ascensia Contour Blood Glucose Monitoring System ( Bayer )Diabetes Care System; Product 7152A.---NO USA Units are affected---.
Terminated
LFRK062058
Aug 11, 2006Roche Diagnostics Corp.
Accu-Chek Inform blood glucose test strips; International Reference nos. 04535057001, 04647696001 and 04535120001.
Terminated
LFRNone listed
Aug 11, 2006Roche Diagnostics Corp.
Accu-Chek Advantage Pro blood glucose test strips; International Reference no. 04534972001.
Terminated
LFRNone listed
Aug 11, 2006Roche Diagnostics Corp.
Accu-Chek Advantage Plus blood glucose test strips; International Reference no. 04735102001.
Terminated
LFRNone listed
Aug 11, 2006Roche Diagnostics Corp.
Accu-Chek Sensor Comfort Pro blood glucose test strips; International Reference nos. 03758770001, 03360652080, 03051188003, 03620115003, and 04535235003.
Terminated
LFRNone listed
Aug 11, 2006Roche Diagnostics Corp.
Accu-Chek Sensor Comfort blood glucose test strips; International Reference nos. 03261956170, 03261964170, 03146154192, 03146146192, 03374700023, 03374718023, 11895133192, 11895141192, 03522091016, 03
Terminated
LFRNone listed
Aug 11, 2006Roche Diagnostics Corp.
Accu-Chek Advantage II blood glucose test strips; International Reference nos. 12030659001, 12030667001, 03137872001, 03137899001, 03000281001, 12030535001, 12030543001, 03033449001, 03033465001 and 1
Terminated
LFRNone listed
Aug 11, 2006Roche Diagnostics Corp.
Accu-Chek Advantage blood glucose test strips; U.S. Reference nos. (packaged in 50s and/or 100s) 03144917001, 03144704001, 03145263001 and International Reference nos. 12030551001, 12030578001 and 120
Terminated
LFRK982089
Aug 11, 2006Roche Diagnostics Corp.
Accu-Chek Comfort Curve blood glucose test strips; (packaged in 10s, 50s, and/or 100s) U.S. Reference nos. 12030420001, 12030373001, 12030381001, 12030365001, 04388208001, 04388186001 and 03000141001.
Terminated
LFRK010362
Aug 5, 2006Roche Diagnostics Corp.
ACCU-CHEK Voicemate System, Advantage Blood Glucose Meter and Voice Unit - Spanish language version for the blind or visually impaired, Cat. no. 3040208. Ref. no. 03040208001 with meter model no. 768
Terminated
LFRK982079
Aug 5, 2006Roche Diagnostics Corp.
ACCU-CHEK Voicemate System, Advantage Blood Glucose Meter and Voice Unit - English language version for the blind or visually impaired, Cat. no 2030802. Ref. no. 12030802001 with meter model no. 768.
Terminated
LFRK982079
Aug 5, 2006Roche Diagnostics Corp.
ACCU-CHEK HQ for Blood Glucose Monitoring and Automated Data Management and Communication; Contents include two Accu-Chek Advantage monitors including Cat. no. 2138018 and Cat. no. 2138026. Ref. nos.
Terminated
LFRK983047
Aug 5, 2006Roche Diagnostics Corp.
ACCU-CHEK Complete blood glucose monitor, Ref. no. 516; Catalog nos. 03266770001 and 03871983001 with meter model no. 200 and Catalog no. 03871983001 with meter model number 250.
Terminated
LFRK973662
Aug 5, 2006Roche Diagnostics Corp.
ACCU-CHEK Complete diabetes monitoring kit/ care kit/ insulin pump therapy kit, Cat. no 515; Ref. nos. 03144852001 and 12031981001 with meter model no. 200 and Ref. no. 03144852001 with meter model no
Terminated
LFRK973662
Feb 28, 2006Roche Diagnostics Corp.
Accu-Chek Inform blood glucose test strips; Reference numbers 04535057001, 04647696001 and 04535120001 (All sold outside of the United States).
Terminated
LFRK010362
K982089
Feb 28, 2006Roche Diagnostics Corp.
Accu-Chek Sensor Comfort Pro blood glucose test strips; Reference numbers 0375877001, 03360652080, 03051188003, 03620115003 and 04535235003 (All sold outside of the United States).
Terminated
LFRK010362
Feb 28, 2006Roche Diagnostics Corp.
Accu-Chek Sensor Comfort blood glucose test strips; Reference numbers 03261956170, 03261964170, 03146154192, 03146146192, 03374700023, 03374718023, 11895133192, 11895141192, 03522091016, 03051161003,
Terminated
LFRK010362
Feb 28, 2006Roche Diagnostics Corp.
Accu-Chek Advantage Pro blood glucose test strips; Reference number 04534972001 (All sold outside of the United States).
Terminated
LFRK982089
Feb 28, 2006Roche Diagnostics Corp.
Accu-Chek Advantage Plus blood glucose test strips; Reference number 04735102001 (All sold outside of the United States).
Terminated
LFRK982089
Feb 28, 2006Roche Diagnostics Corp.
Accu-Chek Advantage II blood glucose test strips; Reference numbers 12030659001, 12030667001, 03137872001, 03137899001, 03000281001, 12030535001, 12030543001, 03033449001, 03033465001 and 12030543047
Terminated
LFRK982089
Feb 28, 2006Roche Diagnostics Corp.
Accu-Chek Advantage blood glucose test strips; Reference numbers 03144917001, 03144704001, 03145263001, (sold within the United States) and 12030551001, 12030578001 and 12030586001 (sold outside of th
Terminated
LFRK982089
Feb 28, 2006Roche Diagnostics Corp.
Accu-Chek Comfort Curve blood glucose test strips; Reference numbers 12030420001, 12030373001, 12030381001, 12030365001, 04388208001, 04388186001 and 03000141001. (Sold in the United States).
Terminated
LFRK010362
Jan 24, 2006Roche Diagnostics Corp.
Roche brand Accu-Chek Aviva Meter (mmol/L); Catalog numbers 03532313001 and 03532321001. (Distributed outside of the U.S.)
Terminated
LFRK043474
Jan 24, 2006Roche Diagnostics Corp.
Roche brand Accu-Chek Aviva Meter (mg/dL); Catalog number 03532356001. (Distributed outside of the U.S.)
Terminated
LFRK043474
Jan 24, 2006Roche Diagnostics Corp.
Roche brand Accu-Chek Aviva Care Kit; Catalog number 04422058170; - Canada Catalog number 04422058164; - Nordics Catalog number 04422040170. (Distributed outside of the U.S.)
Terminated
LFRK043474
Jan 24, 2006Roche Diagnostics Corp.
Roche brand Accu-Chek Aviva Meter (mg/dL); Catalog number 03532275001. (Distributed within the U.S.)
Terminated
LFRK043474
Jan 24, 2006Roche Diagnostics Corp.
Roche brand Accu-Chek Aviva Pediatrics Kit; Catalog number 04593839001. (Distributed within the U.S.)
Terminated
LFRK043474
Jan 24, 2006Roche Diagnostics Corp.
Roche brand Accu-Chek Aviva Bonus Pack Display; Catalog number 045659066001. (Distributed within the U.S.)
Terminated
LFRK043474
Jan 24, 2006Roche Diagnostics Corp.
Roche brand Accu-Chek Aviva Retail Distributor Pack; Catalog number 04578198001. (Distributed within the U.S.)
Terminated
LFRK043474
Jan 24, 2006Roche Diagnostics Corp.
Roche brand Accu-Chek Aviva Bonus Pack; Catalog number 04528247001. (Distributed within the U.S.)
Terminated
LFRK043474
Jan 24, 2006Roche Diagnostics Corp.
Roche brand Accu-Chek Aviva Meter Only Kit; Catalog number 04532279001. (Distributed within the U.S.)
Terminated
LFRK043474
Jan 24, 2006Roche Diagnostics Corp.
Roche brand Accu-Chek Aviva Care Kit; Catalog number 04528280001. (Distributed within the U.S.)
Terminated
LFRK043474
Oct 1, 2005Abbott Diabetes Care, Inc.
FreeStyle CoPilot Web Based Data Management System, and FreeStyle CoPilot Health Management System,Versions 1 and 2. Web-based software system, no packaging.
Terminated
LFRK994433
Sep 15, 2005CHdiagnostics
SeNova Test Strips for Testing Glucose in Whole Blood. Blood glucose test strips for use with the Senova brand meter only. For in vitro diagnostics use. Do not store strips outside vial. Discard
Terminated
LFRK032076
Apr 9, 2003Roche Diagnostics Corp.
Accu-Chek Advantage glucose test strips; part numbers 336, 556, 787 and 966.
Terminated
LFRK982089

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