Au Bicarbonate Reagent
FDA 510(k) K131546 · Beckman Coulter Ireland, Inc.
510(k) numberK131546
Submission
- Device name
- Au Bicarbonate Reagent
- Applicant
- Beckman Coulter Ireland, Inc.
Brea, CA, US - Received
- May 29, 2013
- Decision date
- October 9, 2013
- 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
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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 |
| 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 |
| K093611 | Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT Calibrator Kit…KHS · Traditional | Ortho-Clinical Diagnostics, Inc. | 04/15/2010SE |
More from Ortho-Clinical Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K182651 | HbA1c AdvancedPDJ · Traditional | 01/16/2019SE |
| K161508 | CeruloplasminDDB · Traditional | 01/09/2017SE |
| K161297 | Beta-2-MicroglobulinJZG · Special | 06/07/2016SE |
| K142346 | Urine/CSF Albumin, Urine/CSF Albumin CalibratorDCF · Traditional | 10/15/2014SE |
| K141388 | System CalibraterJIX · Abbreviated | 07/11/2014SE |
| K141374 | Bicarbonate CalibratorJIT · Abbreviated | 06/30/2014SE |
Questions and answers
When was Au Bicarbonate Reagent cleared by the FDA?
Au Bicarbonate Reagent (K131546) received a 510(k) decision of Substantially Equivalent on October 9, 2013, 133 days after the submission was received.
What is the product code of K131546?
The FDA product code is KHS – Enzymatic, Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 862.1160.