Carbon Dioxide - L3K Assay, Catalogue Number 299-30/40/50
FDA 510(k) K990754 · Diagnostic Chemicals , Ltd.
510(k) numberK990754
Submission
- Device name
- Carbon Dioxide - L3K Assay, Catalogue Number 299-30/40/50
- Applicant
- Diagnostic Chemicals , Ltd.
Charlottetown, P.E., CA - Received
- March 8, 1999
- Decision date
- April 20, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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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 |
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| 510(k) | Device | Decision |
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| K070383 | Enzymatic Creatinine Assay (265 Series)JFY · Traditional | 06/22/2007SE |
| K063208 | Magnesium Assay (XB), Models 125-12, 125-50 and 125-S7JGJ · Traditional | 01/19/2007SE |
| K060139 | Crp-Advance Assay, Models 250-20, 250-25DCK · Traditional | 04/28/2006SE |
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| K051191 | DCL Microalbumin Assay, Model 252-20DCF · Traditional | 07/05/2005SE |
| K042330 | Acetaminophen-Sl AssayLDP · Traditional | 01/07/2005SE |
| K042362 | Modification to Carbon DIOXIDE-L3K Assay, Cat. Nos. 299-30, 299-17, 299-50, 299-80 and…KHS · Traditional | 12/27/2004SE |
| K042329 | Salicylate-Sl AssayDKJ · Traditional | 12/27/2004SE |
| K041928 | Hdl-Advance Assay, Cat. No. 278-20, 278-50A, 278-50BLBS · Traditional | 11/23/2004SE |
Questions and answers
When was Carbon Dioxide - L3K Assay, Catalogue Number 299-30/40/50 cleared by the FDA?
Carbon Dioxide - L3K Assay, Catalogue Number 299-30/40/50 (K990754) received a 510(k) decision of Substantially Equivalent on April 20, 1999, 43 days after the submission was received.
What is the product code of K990754?
The FDA product code is KHS – Enzymatic, Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 862.1160.