Elitech Clinical Systems Carbon Dioxide Electrode, Elitech Clinical Systems Ise Calibrators
FDA 510(k) K111960 · Elitechgroup
510(k) numberK111960
Submission
- Device name
- Elitech Clinical Systems Carbon Dioxide Electrode, Elitech Clinical Systems Ise Calibrators
- Applicant
- Elitechgroup
Bothell, WA, US - Received
- July 11, 2011
- Decision date
- November 18, 2011
- 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 |
| 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 |
| K093611 | Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT Calibrator Kit…KHS · Traditional | Ortho-Clinical Diagnostics, Inc. | 04/15/2010SE |
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| K180627 | Macroduct Advanced Model 3710KTB · Traditional | 07/27/2018SE |
| K171401 | ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT…CIG · Traditional | 07/11/2017SE |
| K153644 | ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech…CFR · Traditional | 09/07/2016SE |
| K151113 | ELITech Clinical Systems CALCIUM ARSENAZOCJY · Traditional | 07/22/2015SE |
| K151552 | ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical…JIX · Abbreviated | 07/08/2015SE |
| K141265 | Elitech Clinical Systems Envoy 500 CK Reagent KitJHW · Traditional | 07/18/2014SE |
| K132399 | Elitech Clinical Systems Creatinine Pap SL, Elical 2, Elitrol I and Elitrol II, Urine…JFY · Traditional | 01/03/2014SE |
| K130765 | Elitech Clinical Systems Elical 2; Elitech Clinical Systems Elitrol I, Elitech Clinical…JIX · Abbreviated | 04/04/2013SE |
| K122177 | Elitech Clinical Systems Urine Total Protein Plus Standard 100 Mg/Dl, Elitech Clinical…JIT · Abbreviated | 02/15/2013SE |
Questions and answers
When was Elitech Clinical Systems Carbon Dioxide Electrode, Elitech Clinical Systems Ise Calibrators cleared by the FDA?
Elitech Clinical Systems Carbon Dioxide Electrode, Elitech Clinical Systems Ise Calibrators (K111960) received a 510(k) decision of Substantially Equivalent on November 18, 2011, 130 days after the submission was received.
What is the product code of K111960?
The FDA product code is KHS – Enzymatic, Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 862.1160.