Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1160](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1160) → KHS — Enzymatic, Carbon-Dioxide # KHS · Enzymatic, Carbon-Dioxide _Clinical Chemistry · 21 CFR 862.1160 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHS ## Overview - **Product Code:** KHS - **Device Name:** Enzymatic, Carbon-Dioxide - **Regulation:** [21 CFR 862.1160](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1160) - **Device Class:** 2 - **Review Panel:** [Clinical Chemistry](/submissions/CH) - **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](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHS/K170200.md) | Carbon Dioxide Reagent Set | Teco Diagnostics, Inc. | Jun 1, 2017 | SESE | | [K152085](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHS/K152085.md) | Liquid CO2-2 (LCO2-2) | Randox Laboratories, Ltd. | Feb 24, 2016 | SESE | | [K140248](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHS/K140248.md) | S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2) | Hitachi Chemical Diagnostics, Inc. | Mar 11, 2014 | SESE | | [K131546](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHS/K131546.md) | AU BICARBONATE REAGENT | Beckman Coulter Ireland, Inc. | Oct 9, 2013 | SESE | | [K123953](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHS/K123953.md) | 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](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHS/K120765.md) | VITROS CHEMISTRY PRODUCTS ECO2 SLIDES | Ortho-Clinical Diagnostics, Inc. | Oct 24, 2012 | SESE | | [K113435](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHS/K113435.md) | ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT | Alfa Wassermann | Jul 2, 2012 | SESE | | [K111960](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHS/K111960.md) | ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS | Elitechgroup | Nov 18, 2011 | SESE | | [K100060](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHS/K100060.md) | EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475 | Vital Diagnostics (Manufacturing) Ptyltd | Dec 15, 2010 | SESE | | [K100289](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHS/K100289.md) | ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, 07506781 | Siemens Healthcare Diagnostics | May 10, 2010 | SESE | | [K093611](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHS/K093611.md) | 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](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHS/K091153.md) | SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291 | Beckman Coulter, Inc. | Jul 13, 2009 | SESE | | [K073223](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHS/K073223.md) | S-TEST C02 | Alfa Wassermann Diagnostic Technologies, Inc. | Jun 26, 2008 | SESE | | [K071340](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHS/K071340.md) | CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL | Thermofisher Scientific OY | Oct 5, 2007 | SESE | | [K070251](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHS/K070251.md) | CARBON DIOXIDE LIQUID STABLE REAGENT | Pointe Scientific, Inc., | Apr 30, 2007 | SESE | | [K060619](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHS/K060619.md) | DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A | Diazyme Laboratories | Jul 21, 2006 | SESE | | [K061238](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHS/K061238.md) | DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | May 25, 2006 | SESE | | [K060295](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHS/K060295.md) | CARBON DIOXIDE | Abbott Laboratories | May 4, 2006 | SESE | | [K042362](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHS/K042362.md) | 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](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHS/K032377.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHS](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHS) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com