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Panels › Clinical Chemistry › Product code CGA · Class 2

Glucose Oxidase, Glucose

Regulation 862.1345

1510(k)s in 12 months (401 all time)
0recalls in 12 months (89 all time)
79recalls that name a 510(k)
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Top companies in CGA

Company510(k)sRecalls
Lifescan, Inc.215
Roche Diagnostics Corp.320
Boehringer Mannheim Corp.170
Apex BioTechnology Corp.140
Abbott Point of Care, Inc.66
Miles Laboratories, Inc.120
Nova Biomedical Corp.75
Instrumentation Laboratory CO92
Medisense, Inc.110
Heraeus Kulzer, Inc.100
DateFirm and productCodeLinked 510(k)
Feb 1, 2008ARKRAY USA INC.
Assure 3 Blood Glucose Test Strips, For in vitro Diagnostic use. Product Number: 555050, Control Solution Range (mg/dL). Manufactured for Hypoguard, Minneapolis, MN 55439 USA. Made in Taiwan.
Terminated		 CGAK002621
K011233
Dec 13, 2007ARKRAY USA INC.
Hypoguard Advance Micro-draw Blood Glucose Monitoring System, Product Number : 411100, For In Vitro Diagnostic Use, Manufactured for ARKRAY USA, Inc., Minneapolis, MN 55439 USA. (Package Contents
Terminated		 CGANone listed
Jan 5, 2007Lifescan Inc
LifeScan brand One Touch -Sure Step Pro- Blood Glucose Monitoring System Test Strips, 50 strips per package, Distributed and Manufactured by: LifeScan, Inc., 1000 Gibraltar Drive, Milpitas, CA 95037
Terminated		 CGAK023194
Dec 29, 2006Royal Global Wholesale
OneTouch Basic/Profile Blood Glucose test strips. For use with One Touch Brand Meters blood glucose meters
Terminated		 CGANone listed
Dec 16, 2006Milwaukee Notions, Inc
OneTouchBasic/Profile and OneTouch Ultra- Blood Glucose test strips. For use with ONE TOUCH Brand Meters.
Terminated		 CGANone listed
Dec 16, 2006Medical Plastics Devices Inc
One Touch Ultra Blood Glucose Test Strips
Terminated		 CGANone listed
Nov 4, 2006Ortho-Clinical Diagnostics
VITROS Chemistry Products GLU DT Slides GEN 56, REF (Catalog #) 153 2316, 25 slides per box. VITROS Chemistry Products GLU DT Slides quantitatively measure glucose (GLU) concentration in serum and pla
Terminated		 CGAK841503
Aug 5, 2006Roche Diagnostics Corp.
ACCU-CHEK Advantage FPO Diabetes Monitoring Kit, Cat. no. 3271358001. Ref. no. 03271358001 with meter model no. 3288650.
Terminated		 CGAK930979
Aug 5, 2006Roche Diagnostics Corp.
GTS Advantage Meter. Cat. no. 424. Ref. no. 03144780001 with meter model no. 777.
Terminated		 CGAK924475
Aug 5, 2006Roche Diagnostics Corp.
AccuData GTS Plus AccuData GTS For Blood Glucose Monitoring and Automated Data Management, contents Accu-Chek Advantage repalcement Meter and module, cat. no. 454; Ref. no. 03144798001 contains meter
Terminated		 CGAK924475
Aug 5, 2006Roche Diagnostics Corp.
AccuData GTS Plus for Blood Glucose Monitoring and Automated Data Management including GTS Plus with Accu-Chek Advantage blood glucose meter, Cat no. 3000249 and/or GTS with Accu-Chek Advantage blood
Terminated		 CGAK924475
Aug 5, 2006Roche Diagnostics Corp.
ACCU-CHEK Advantage (Consignment kit), Cat. no. 3000320; catalog no. 03000320001 with meter model no. 2138930.
Terminated		 CGAK930979
Aug 5, 2006Roche Diagnostics Corp.
ACCU-CHEK Advantage (Conversion Kit),Cat. no. 3000338; Ref no. 03000338001 with meter model no. 2138930.
Terminated		 CGAK930979
Aug 5, 2006Roche Diagnostics Corp.
ACCU-CHEK Advantage (Managed Care Kit) 100- value memory with time and date, Not for Retail Sale, Cat. No. 3000389; Ref no. 03000389001 with meter model no. 2138930.
Terminated		 CGAK930979
Aug 5, 2006Roche Diagnostics Corp.
ACCU-CHEK Comfort Curve. Cat. No. 3149030; Ref. number 0314903001 with meter model number 2138930.
Terminated		 CGAK930979
Aug 5, 2006Roche Diagnostics Corp.
ACCU-CHEK Comfort Curve, Cat. No. 2139634. Ref. numbers 03856348001 and 12139642001 both with meter model number 2138930.
Terminated		 CGAK930979
Aug 5, 2006Roche Diagnostics Corp.
ACCU-CHEK Advantage Blood Glucose Meter, Cat. No. 3332586; Ref. no. 03332586001 with meter model no. 2138930.
Terminated		 CGAK930979
Aug 5, 2006Roche Diagnostics Corp.
ACCU-CHEK Advantage Blood Glucose Meter, Cat. No. 2137500; Ref. no. 0385633001 with meter model no. 768.
Terminated		 CGAK930979
Aug 5, 2006Roche Diagnostics Corp.
ACCU-CHEK Advantage Complete Diabetes Monitoring Kit, Cat. No. 860. Ref. no. 080086000 with meter model number 870; Ref. no. 03002531001 with meter model number 33304510; Ref. no. 03002531001 with me
Terminated		 CGAK930979
Aug 5, 2006Roche Diagnostics Corp.
ACCU-CHEK Advantage Blood Glucose Meter/ Blood Glucose Monitoring System; Cat. no. 870. Ref. no. 080087000 with meter model number 870; Ref. no.0353756001 with meter model number 33304510; Ref. no.
Terminated		 CGAK930979
Jan 24, 2006Lifescan Inc
LifeScan OneTouch Ultra Test strips, lot number 2528640
Terminated		 CGAK043197
Jan 11, 2006Instrumentation Laboratory Co.
GEM PREMIER 3000
Terminated		 CGAK052121
Jan 7, 2006Roche Diagnostics Corp.
Roche brand Omni S6 Blood Gas Analyzer; Catalog # 03337154001.
Terminated		 CGANone listed
Jan 7, 2006Roche Diagnostics Corp.
Roche brand Omni S4 Blood Gas Analyzer; Catalog # 03337138001.
Terminated		 CGANone listed
Oct 28, 2005Lifescan Inc
Lifescan OneTouch SureStep Meter Blood Glucose monitoring system,Product is distributed by LifeScan, Inc., 1000 Gibraltar Dr., Milpitas, CA 95037
Terminated		 CGAK023832
Jul 13, 2005Roche Diagnostics Corp.
ACCU-CHEK Instant Care Kit; Catalog number 91490.
Terminated		 CGAK952875
Jul 13, 2005Roche Diagnostics Corp.
ACCU-CHEK Instant Meter; Catalog numbers 914 and 924.
Terminated		 CGAK952875
Jun 14, 2005Lifescan Inc
LifeScan brand OneTouch Ultra Test Strip used in LifeScan Blood Glucose Meter; Part Number 020-244-07; Distributed and Manufactured by: LifeScan, Inc., 1000 Gibraltar Drive, Milpitas, CA 95037
Terminated		 CGAK024194
Jun 11, 2005Roche Diagnostics Corp.
Roche brand AccuData GTS/GTS Plus System Replacement Base/Module; Catalog number 3426050, material number 03426050001.
Terminated		 CGAK924475
Jun 11, 2005Roche Diagnostics Corp.
Roche brand AccuData GTS System; Catalog number 404, material number 03136833001.
Terminated		 CGAK924475
Jun 11, 2005Roche Diagnostics Corp.
Roche brand AccuData GTS Plus System; Catalog number 3000249, material number 03000249001.
Terminated		 CGAK924475
Jul 20, 2004AmeriSource Bergen
MediSense Precision QID Blood Glucose Test Strips. The product is sold in box of 50 and 100. The NDC number for the 50 count box is 57599-7400-4. The NDC number for the 100 count box is 57599-7401-5.
Terminated		 CGANone listed
Jun 22, 2004Osmetech Inc
Osmetech OPTI-CCA Blood Gas Analyzer, Single Use, BP7564 OPTIE-Glu Cassettes.The cassettes are labeled, Roche OPTICCA Cassettes E-Glu. There are 25 cassettes in each box.
Terminated		 CGANone listed
Dec 25, 2003Hypoguard USA, Inc.
Hypoguard Advance Blood Glucose Monitoring System, includes Hypoguard Advance Blood Glucose Meter and 10 Hypoguard Advance Blood Glucose Strips
Terminated		 CGAK020232
Dec 25, 2003Hypoguard USA, Inc.
Hypoguard Advance Blood Glucose Strips, 10, 50, and 100 strip bottles.
Terminated		 CGAK020232
Sep 11, 2003Ortho-Clinical Diagnostics
Vitros Chemistry *** GLU (glucose) DT Slides ***25 slides per box *** CAT 153 2316 *** Ortho-Clinical Diagnostics Inc. , 100 Indigo Creek Dr., Rochester, NY 14626. [NOTE: product has a 24-month
Terminated		 CGAK841503
Sep 11, 2003Ortho-Clinical Diagnostics
Vitros Chemistry *** GLU (glucose) Slides *** 5 cartridges each containing 60 slides for a total of 300 tests per box *** REF 170 7801 *** Ortho-Clinical Diagnostics Inc., 100 Indigo Creek Drive, R
Terminated		 CGAK955286
Mar 12, 2003Lifescan Inc
OneTouch SureStep Glucose Test Strips (consumer use); OneTouch SureStep Pro Glucose Test Strips (hospital use)
Terminated		 CGAK970556
Dec 31, 2002Abbott Laboratories, Inc.
Precision PCx Test Strips Part Number: 98757-12
Terminated		 CGAK983504

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