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)
Top companies in CGA
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2025 | HemoCue 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 |
CGA | K020935 |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office HEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE. Open, Classified |
CGA | K911141 |
| Apr 30, 2024 | Alere San Diego, Inc. Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170 Open, Classified |
CGA | K120615 |
| Oct 31, 2023 | Randox Laboratories Ltd. RX Monaco-IVD Clinical Chemistry Analyser
Catalog Number: RX5000 Open, Classified |
CGA | None listed |
| Oct 31, 2023 | Randox Laboratories Ltd. RX Modena-IVD Clinical Chemistry Analyser
Catalog Number: RX9000 Open, Classified |
CGA | None listed |
| Oct 31, 2023 | Randox Laboratories Ltd. RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser
Catalog Number: RX4040 Open, Classified |
CGA | K024014 |
| Aug 16, 2022 | Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. PTS Panels CHOL+GLU Test Strips (REF 1765) Completed |
CGA | K162282 |
| Jun 24, 2022 | Alere 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 |
CGA | K120615 |
| Aug 28, 2020 | Siemens 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 |
CGA | K200107 |
| Sep 18, 2019 | Medline Industries Inc EVENCARE G3 Blood Glucose Test Strips, 1 test strip per foil pouch, 50 foil pouches per box, 12 boxes per case. Terminated |
CGA | K120448 |
| Jun 17, 2019 | Ortho-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 |
CGA | K182072 K955286 |
| Jan 16, 2019 | Polymer Technology Systems, Inc. CHOL+HDL+GLU test strips, REF 2412 Terminated |
CGA | K071507 K182781 |
| Dec 29, 2016 | Sterling 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 |
CGA | K854335 |
| Aug 11, 2016 | Ortho-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 |
CGA | K955286 |
| Mar 17, 2016 | Siemens Healthcare Diagnostics, Inc. ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA Chemistry Glucose & Concentrated Glucose Oxidase Assay and ADVIA Chemistry Glucose. Terminated |
CGA | K042015 |
| Jan 15, 2016 | Arkray 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 |
CGA | K053401 |
| Jan 15, 2016 | Arkray 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 |
CGA | K041427 |
| Nov 5, 2015 | ELITech 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 |
CGA | K100525 |
| Nov 5, 2015 | ELITech 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 |
CGA | K100525 |
| Nov 5, 2015 | ELITech 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 |
CGA | K100525 |
| Nov 5, 2015 | ELITech 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 |
CGA | K100525 |
| Jul 2, 2015 | Siemens 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 |
CGA | K073537 |
| Jul 2, 2015 | Siemens 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 |
CGA | K031560 |
| Feb 2, 2015 | Roche Diagnostics Operations, Inc. Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer Terminated |
CGA | K032311 |
| Dec 24, 2014 | Radiometer 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 |
CGA | K020935 |
| Jul 22, 2014 | DIABETIC 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 |
CGA | K120183 |
| Jun 25, 2014 | JAS Diagnostics Inc. Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum. Terminated |
CGA | K011900 |
| Jan 9, 2014 | Nova 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 |
CGA | K060345 K063821 +1 |
| Nov 22, 2013 | Alere 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 |
CGA | K120615 |
| Nov 15, 2013 | Ortho-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 |
CGA | K955286 |
| Sep 11, 2013 | HemoCue 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 |
CGA | K020935 |
| Aug 14, 2013 | Epocal 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 |
CGA | K090109 K093297 |
| Apr 19, 2013 | Nova Biomedical Corporation Nova StatStrip Xpress Glu-Test Strips (Glucose test strips)
Catalog # 51493 (UK Only) Terminated |
CGA | K063821 |
| Apr 19, 2013 | Nova Biomedical Corporation Nova StatStrip Xpress Glu-Test Strips (Glucose test strips)
Catalog # 42214 Terminated |
CGA | K063821 |
| Jul 19, 2012 | Epocal 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 |
CGA | K090109 |
| Jan 20, 2012 | Hemo 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 |
CGA | K020935 |
| Jun 1, 2011 | Biosite 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 |
CGA | K904082 |
| May 10, 2011 | Instrumentation 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 |
CGA | K093623 |
| Mar 30, 2011 | Hemo Cue, Inc. HEMOCUE AB GLUCOSE 201 DM ANALYZER, in vitro diagnostic device for quantitative determination of blood glucose level. Terminated |
CGA | K041230 |
| Dec 10, 2010 | Abbott 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 |
CGA | K001387 |
| Dec 10, 2010 | Abbott 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 |
CGA | K001387 |
| Sep 23, 2010 | Abbott 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 |
CGA | K001387 |
| Sep 9, 2010 | Beckman 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 |
CGA | K011213 K023049 +3 |
| Jun 10, 2010 | Nova 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 |
CGA | K060345 K063821 +1 |
| Mar 15, 2010 | Abbott 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 |
CGA | K001387 |
| Mar 5, 2010 | Polymer 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 |
CGA | K071507 |
| Feb 24, 2010 | Abbott 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 |
CGA | K001387 |
| Sep 30, 2009 | Abbott 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 |
CGA | K001387 |
| Mar 12, 2009 | Pointe 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 |
CGA | K810674 |
| Sep 23, 2008 | Nova 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 |
CGA | K060345 K070068 |
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