Abbott Quickstart Bicarbonate Test CO2 Item# 5A22
FDA 510(k) K912806 · Em Diagnostic Systems, Inc.
510(k) numberK912806
Submission
- Device name
- Abbott Quickstart Bicarbonate Test CO2 Item# 5A22
- Applicant
- Em Diagnostic Systems, Inc.
Gibbstown, NJ, US - Received
- June 25, 1991
- Decision date
- September 11, 1991
- 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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| K935178 | Emds Phosphorous (Phos) TestCEO · Traditional | 12/17/1993SE |
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| K935175 | Lactate Dehydrogenase (LD)CFJ · Traditional | 12/16/1993SE |
| K935174 | Total Protein Test (Tpro)CEK · Traditional | 12/16/1993SE |
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Questions and answers
When was Abbott Quickstart Bicarbonate Test CO2 Item# 5A22 cleared by the FDA?
Abbott Quickstart Bicarbonate Test CO2 Item# 5A22 (K912806) received a 510(k) decision of Substantially Equivalent on September 11, 1991, 78 days after the submission was received.
What is the product code of K912806?
The FDA product code is KHS – Enzymatic, Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 862.1160.