S-Test C02
FDA 510(k) K073223 · Alfa Wassermann Diagnostic Technologies, Inc.
510(k) numberK073223
Submission
- Device name
- S-Test C02
- Applicant
- Alfa Wassermann Diagnostic Technologies, Inc.
West Caldwell, NJ, US - Received
- November 15, 2007
- Decision date
- June 26, 2008
- 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
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|---|---|---|---|
| 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 |
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| K170623 | ACE Hemoglobin A1c (HbA1c) ReagentLCP · Traditional | 02/27/2018SE |
| K131975 | Ace Direct Total Iron-Binding Capacity (Tibc) Reagent, Ace Total Iron Reagent, Ace Ldh-L…CFJ · Traditional | 10/02/2013SE |
| K131351 | Ace Alkaline Phosphatase Reagent, Amylase Reagent, Alt Reagent, Ast ReagentCJE · Traditional | 08/15/2013SE |
| K123953 | Ace Carbon Dioxide Reagent, Ace Direct Biliubin Reagent, Ace Total Bilirubin Reagent…KHS · Traditional | 05/02/2013SE |
| K123018 | Ace Alera Clinical Chemistry System, Ace Glucose Reagent, Ace Ion Selective Electrode…CFR · Traditional | 04/23/2013SE |
| K122757 | Ace Cholesterol Reagent, Ace Hdl-C Reagent, Ace Ldl-C Reagent, Ace Triglycerides ReagentCHH · Traditional | 10/05/2012SE |
| K113389 | Ace CK Reagent,Ace Bun/Urea Reagent,Ace Uric Acid Reagent,Ace Creatinine ReagentCDN · Traditional | 08/10/2012SE |
| K113437 | Ace Hemoglobin Alc(Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace T4 Reagent, Ace…LCP · Traditional | 08/06/2012SE |
| K113374 | Ace Albumin Reagent Ace Total Protein Reagent Ace Calcium-Arsenazo Reagent Ace…CIX · Traditional | 07/13/2012SE |
| K113262 | Ace Cholesterol Reagent, Ace Hdl-C Reagent, Ace Ldl-C Reagent-C, Ace-Trislycerides ReagentCHH · Traditional | 07/03/2012SE |
Questions and answers
When was S-Test C02 cleared by the FDA?
S-Test C02 (K073223) received a 510(k) decision of Substantially Equivalent on June 26, 2008, 224 days after the submission was received.
What is the product code of K073223?
The FDA product code is KHS – Enzymatic, Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 862.1160.