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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

DateFirm and productCodeLinked 510(k)
Jul 2, 2025HemoCue AB
The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma conversion that multiplies the measured whole blood glucose value by a factor of 1.
Open, Classified
CGAK020935
May 27, 2025Mckesson Medical-Surgical Inc. Corporate Office
HEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE.
Open, Classified
CGAK911141
Apr 30, 2024Alere San Diego, Inc.
Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170
Open, Classified
CGAK120615
Oct 31, 2023Randox Laboratories Ltd.
RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000
Open, Classified
CGANone listed
Oct 31, 2023Randox Laboratories Ltd.
RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000
Open, Classified
CGANone listed
Oct 31, 2023Randox Laboratories Ltd.
RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040
Open, Classified
CGAK024014
Aug 16, 2022Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
PTS Panels CHOL+GLU Test Strips (REF 1765)
Completed
CGAK162282
Jun 24, 2022Alere San Diego, Inc.
The Cholestech LDX System combines enzymatic methodology and solidphase technology to measure total cholesterol, HDL cholesterol, triglycerides and glucose. Samples used for testing can be whole blood
Open, Classified
CGAK120615
Aug 28, 2020Siemens Healthcare Diagnostics Inc
Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the
Terminated
CGAK200107
Sep 18, 2019Medline Industries Inc
EVENCARE G3 Blood Glucose Test Strips, 1 test strip per foil pouch, 50 foil pouches per box, 12 boxes per case.
Terminated
CGAK120448
Jun 17, 2019Ortho-Clinical Diagnostics
VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid
Terminated
CGAK182072
K955286
Jan 16, 2019Polymer Technology Systems, Inc.
CHOL+HDL+GLU test strips, REF 2412
Terminated
CGAK071507
K182781
Dec 29, 2016Sterling Diagnostics, Inc.
Sterling Diagnostics, Inc., Enzymatic Glucose for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
Terminated
CGAK854335
Aug 11, 2016Ortho-Clinical Diagnostics
VITROS Chemistry Products GLU Slides, REF/Product Code 170 7801 (300 slides per sales unit), Unique Device Identifier No. 10758750009572, Rx ONLY, IVD --- For in vitro diagnostic use only. VITROS C
Terminated
CGAK955286
Mar 17, 2016Siemens Healthcare Diagnostics, Inc.
ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA Chemistry Glucose & Concentrated Glucose Oxidase Assay and ADVIA Chemistry Glucose.
Terminated
CGAK042015
Jan 15, 2016Arkray Factory USA, Inc.
arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, Product # 11726, MEDTEST DX Catalog # 77484. Calcium, Blood Urea Nitrogen, Glucose, Albumin, Creatinine. For the in vitro quantitative determi
Terminated
CGAK053401
Jan 15, 2016Arkray Factory USA, Inc.
arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424. For the in vitro quantitative determination of glucose in human plasma from whole blood samples.
Terminated
CGAK041427
Nov 5, 2015ELITech Clinical Systems SAS
Envoy 500 system includes the following product reference numbers and names: 55345 ENVOY 500 Glucose 55450 ENVOY 500 URIC ACID REAGENT KIT 55435 ENVOY 500 TRIGLYCERIDES REAGENT KIT, 55297 ENVOY 500
Terminated
CGAK100525
Nov 5, 2015ELITech Clinical Systems SAS
ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize the Trinder Reaction method. The following product reference numbers and names: GPSL-025O: Glucose PAP SL A
Terminated
CGAK100525
Nov 5, 2015ELITech Clinical Systems SAS
Eon 300 system includes the following product reference numbers and names: Reference no. 79345 Glucose (GPSL) Reference no. 79450 Uric acid (AUVD) Reference no. 79435 Triglycerides (TGML) Reference
Terminated
CGAK100525
Nov 5, 2015ELITech Clinical Systems SAS
Eon 100 system included the following product reference numbers and names: Reference no. 77345- Glucose (GPSL) Reference no. 77450- Uric acid (AUVD) Reference no. 77435- Triglycerides (TGML) Refere
Terminated
CGAK100525
Jul 2, 2015Siemens Healthcare Diagnostics, Inc
The Rapidlab 1265 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in arterial, venous and capillary whole blood samples.
Terminated
CGAK073537
Jul 2, 2015Siemens Healthcare Diagnostics, Inc
The Rapidlab 1260 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in arterial, venous and capillary whole blood samples.
Terminated
CGAK031560
Feb 2, 2015Roche Diagnostics Operations, Inc.
Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
Terminated
CGAK032311
Dec 24, 2014Radiometer America Inc
HemoCue Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the HemoCue Glucose 201 DM Analyzer (hereafter referred to as the
Terminated
CGAK020935
Jul 22, 2014DIABETIC SUPPLY OF SUNCOAST, INC.
ADVOCATE Redi-Code+ BMB-BA006A Blood Glucose test strips Product Usage: The ADVOCATE Redi-Code+ BMB-BA006A Blood Glucose test strips are used only with the ADVOCATE Redi-Code+ BMB-EA004S meter to qu
Terminated
CGAK120183
Jun 25, 2014JAS Diagnostics Inc.
Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.
Terminated
CGAK011900
Jan 9, 2014Nova Biomedical Corporation
Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Creatinine Hospital Meter, Rechargeable Lithium Batteries Single: 46626; 4 Pack:
Terminated
CGAK060345
K063821 +1
Nov 22, 2013Alere San Diego, Inc.
Product Brand Name(s): Alere Cholestech LDX Lipid Profile"GLU Test Cassette, Model 10-991. Product Generic Name: Alere Cholestech LDX Lipid Profile"GLU Test Cassette. Description of the product: Lipid
Terminated
CGAK120615
Nov 15, 2013Ortho-Clinical Diagnostics
VITROS Chemistry Products GLU Slides packaged as 300 slides/pack catalog number 1707801 VITROS GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine and cerebrospinal f
Terminated
CGAK955286
Sep 11, 2013HemoCue AB
HemoCue Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 2
Terminated
CGAK020935
Aug 14, 2013Epocal
epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate and Hematocrit.
Terminated
CGAK090109
K093297
Apr 19, 2013Nova Biomedical Corporation
Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 51493 (UK Only)
Terminated
CGAK063821
Apr 19, 2013Nova Biomedical Corporation
Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214
Terminated
CGAK063821
Jul 19, 2012Epocal Inc
epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System Product Usage: Usage: epoc Blood Analysis BGEM Test Cards are used with the epoc(R) Blood Analysis System which is
Terminated
CGAK090109
Jan 20, 2012Hemo Cue, Inc.
HemoCue Glucose 201 Microcuvettes, Article Number:110705*,110706,110715**,110716**,110717**,110718**, 110719** " No affected lots of this article have been delivered to customers. Still in stock a
Terminated
CGAK020935
Jun 1, 2011Biosite Inc Dba Innovacon Inc.
Cholestech LDX Lipid Profile"GLU test cassettes, Catalog Number 10-991, Lot # 245104 Cholestech LDX Lipid-Glucose tests are intended for the quantitative determination of total cholesterol, HDL (high
Terminated
CGAK904082
May 10, 2011Instrumentation Laboratory Co.
Instrumentation Laboratory GEM Premier 4000 PN 00025000000 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the p
Terminated
CGAK093623
Mar 30, 2011Hemo Cue, Inc.
HEMOCUE AB GLUCOSE 201 DM ANALYZER, in vitro diagnostic device for quantitative determination of blood glucose level.
Terminated
CGAK041230
Dec 10, 2010Abbott Point Of Care Inc.
Military Kit Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the
Terminated
CGAK001387
Dec 10, 2010Abbott Point Of Care Inc.
i-STAT Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat
Terminated
CGAK001387
Sep 23, 2010Abbott Point of Care Inc.
GCX Mountable Downloader-Recharger; (accessory to the i-STAT Portable Clinical Analyzer (model 300). The GCX Mountable Downloader-Recharger (GCX) is a connectivity component that is intended to be mou
Terminated
CGAK001387
Sep 9, 2010Beckman Coulter Inc.
GLUCm used on Synchron LX and UniCel DxC Synchron Clinical Systems, Part Number: 472500 ( ynchron LX20, LX20 PRO, LXI 725, UniCel DxC 600, UniCel DxC 600 PRO, UniCel DxC 600i, UniCel DxC 800, UniCel D
Terminated
CGAK011213
K023049 +3
Jun 10, 2010Nova Biomedical Corporation
Nova StatStrip Glucose Test Strips, Catalog Number: 42214. Nova Biomedical Corporation. Waltham, MA 02454. Intended for in vitro diagnostic use by health care professionals and for Point-Of-Care us
Terminated
CGAK060345
K063821 +1
Mar 15, 2010Abbott Point of Care Inc.
Martel Printer The Martel Printer is an accessory to the i-STAT Portable clinical Analyzer (model 300). The i-STAT Analyzer is used by trained medical professionals for running a variety of clinical
Terminated
CGAK001387
Mar 5, 2010Polymer Technology Systems, Inc.
PTS Panels CHOL+HDL+GLU Panel test strips for professional use with CardioChek P-A analyzers, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.
Terminated
CGAK071507
Feb 24, 2010Abbott Point of Care Inc.
i-STAT 1 Analyzer, Abbott Point of Care Inc., Abbott Park, IL 60064 USA, Product of USA. The product is intended to be used by trained medical professionals for use with i-STAT test cartridges and M
Terminated
CGAK001387
Sep 30, 2009Abbott Point of Care Inc.
Martel Printer Accessory to i-STAT Portable Clinical Analyzer, rechargeable battery pack. Printing results of clinical chemistry tests and test panels contained in the i-STAT test cartridges.
Terminated
CGAK001387
Mar 12, 2009Pointe Scientific, Inc.
Glucose Oxidase Reagent as follows: Pointe Scientific Glucose Oxidase Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # G7519-1L, G7519-500 and G7519-SAM. 2MM Diagnostics Glucose Oxidase Re
Terminated
CGAK810674
Sep 23, 2008Nova Biomedical Corporation
Varta Easypack XL Lithium Polymer Batteries (P/N 41772 and 42215) Used with: Nova Biomedical StatStrip Glucose Hospital Meter (P/N 42224) and Nova Biomedical StatSensor Creatinine Hospital Meter and
Terminated
CGAK060345
K070068

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