KHS · Enzymatic, Carbon-Dioxide
Clinical Chemistry · 21 CFR 862.1160 · Class 2
Overview
| Product Code | KHS |
|---|---|
| Device Name | Enzymatic, Carbon-Dioxide |
| Regulation | 21 CFR 862.1160 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 86)
Showing 20 most recent of 86 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K170200 | Carbon Dioxide Reagent Set | Teco Diagnostics, Inc. | Jun 1, 2017 | SESE |
| K152085 | Liquid CO2-2 (LCO2-2) | Randox Laboratories, Ltd. | Feb 24, 2016 | SESE |
| K140248 | S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2) | Hitachi Chemical Diagnostics, Inc. | Mar 11, 2014 | SESE |
| K131546 | AU BICARBONATE REAGENT | Beckman Coulter Ireland, Inc. | Oct 9, 2013 | SESE |
| K123953 | ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT | Alfa Wassermann Diagnostic Technologies, Inc. | May 2, 2013 | SESE |
| K120765 | VITROS CHEMISTRY PRODUCTS ECO2 SLIDES | Ortho-Clinical Diagnostics, Inc. | Oct 24, 2012 | SESE |
| K113435 | ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT | Alfa Wassermann | Jul 2, 2012 | SESE |
| K111960 | ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS | Elitechgroup | Nov 18, 2011 | SESE |
| K100060 | EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475 | Vital Diagnostics (Manufacturing) Ptyltd | Dec 15, 2010 | SESE |
| K100289 | ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, 07506781 | Siemens Healthcare Diagnostics | May 10, 2010 | SESE |
| K093611 | VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002; | Ortho-Clinical Diagnostics, Inc. | Apr 15, 2010 | SESE |
| K091153 | SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291 | Beckman Coulter, Inc. | Jul 13, 2009 | SESE |
| K073223 | S-TEST C02 | Alfa Wassermann Diagnostic Technologies, Inc. | Jun 26, 2008 | SESE |
| K071340 | CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL | Thermofisher Scientific OY | Oct 5, 2007 | SESE |
| K070251 | CARBON DIOXIDE LIQUID STABLE REAGENT | Pointe Scientific, Inc., | Apr 30, 2007 | SESE |
| K060619 | DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A | Diazyme Laboratories | Jul 21, 2006 | SESE |
| K061238 | DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | May 25, 2006 | SESE |
| K060295 | CARBON DIOXIDE | Abbott Laboratories | May 4, 2006 | SESE |
| K042362 | MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12 | Diagnostic Chemicals , Ltd. | Dec 27, 2004 | SESE |
| K032377 | ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID | Roche Diagnostics Corp. | Aug 21, 2003 | SESE |
Top Applicants
- Em Diagnostic Systems, Inc. — 7 clearances
- Abbott Laboratories — 4 clearances
- Boehringer Mannheim Corp. — 4 clearances
- Data Medical Associates, Inc. — 4 clearances
- Diagnostic Chemicals , Ltd. — 4 clearances
