CO2
FDA 510(k) K981231 · Abbott Mfg., Inc.
510(k) numberK981231
Submission
- Device name
- CO2
- Applicant
- Abbott Mfg., Inc.
Irving, TX, US - Received
- April 3, 1998
- Decision date
- May 12, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KHS – Enzymatic, Carbon-Dioxide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1160
- Specialty
- Clinical Chemistry
Other 510(k)s with product code KHS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K170200 | Carbon Dioxide Reagent SetKHS · Traditional | Teco Diagnostics, Inc. | 06/01/2017SE |
| K152085 | Liquid CO2-2 (LCO2-2)KHS · Traditional | Randox Laboratories, Ltd. | 02/24/2016SE |
| K140248 | S Test Reagent Cartridge Carbon Dioxide (CO2)KHS · Traditional | Hitachi Chemical Diagnostics, Inc. | 03/11/2014SE |
| K131546 | Au Bicarbonate ReagentKHS · Traditional | Beckman Coulter Ireland, Inc. | 10/09/2013SE |
| K123953 | Ace Carbon Dioxide Reagent, Ace Direct Biliubin Reagent, Ace Total Bilirubin Reagent…KHS · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 05/02/2013SE |
| K120765 | Vitros Chemistry Products ECO2 SlidesKHS · Special | Ortho-Clinical Diagnostics, Inc. | 10/24/2012SE |
| K113435 | Ace Carbon DIOXIDE(CO2-LC) Reagent, Ace Direct Bilirubin Reagent, Ace Total Bilirubin…KHS · Traditional | Alfa Wassermann | 07/02/2012SE |
| K111960 | Elitech Clinical Systems Carbon Dioxide Electrode, Elitech Clinical Systems Ise…KHS · Traditional | Elitechgroup | 11/18/2011SE |
| K100060 | Eon 100 Chemistry Analyzer with Ise , Model 77105, Bicarbonate Reagent, Model 77475KHS · Traditional | Vital Diagnostics (Manufacturing) Ptyltd | 12/15/2010SE |
| K100289 | Advia Chemistry Systems Carbon Dioxide Liquid (C02_L) Assay, Model Ref 07987100, 07506781KHS · Traditional | Siemens Healthcare Diagnostics | 05/10/2010SE |
More from Siemens Healthcare Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K981457 | AlbpCJW · Traditional | 05/27/1998SE |
| K981232 | CaCJY · Traditional | 05/18/1998SE |
| K965230 | Abbott Lifecare Standard Tubing Infusion PumpFRN · Traditional | 07/03/1997SE |
| K971293 | Lifeshield Primary I.V. Set with Backcheck ValveFPA · Traditional | 06/27/1997SE |
| K953656 | Abbott Imx Prolactin(Modification)CFT · Traditional | 10/03/1995SE |
| K953657 | Abbott Axsym Prolactin(Modification)CFT · Traditional | 09/25/1995SE |
| K944669 | Flexiflo Quantum Enteral PumpFRN · Traditional | 07/24/1995SE |
| K943691 | Imx FolateCGN · Traditional | 03/23/1995SE |
| K943733 | Flexiflo Six Enteral Nutrition PumpLZH · Traditional | 12/12/1994ST |
| K941214 | Lifeshield Extension SetFPK · Traditional | 10/03/1994SE |
Questions and answers
When was CO2 cleared by the FDA?
CO2 (K981231) received a 510(k) decision of Substantially Equivalent on May 12, 1998, 39 days after the submission was received.
What is the product code of K981231?
The FDA product code is KHS – Enzymatic, Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 862.1160.