epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test
FDA 510(k) K171247 · Epocal, Inc.
510(k) numberK171247
Submission
- Device name
- epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test
- Applicant
- Epocal, Inc.
Ottawa, CA - Received
- April 28, 2017
- Decision date
- January 17, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CDS – Electrode, Ion Specific, Urea Nitrogen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1770
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CDS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K040973 | Bun ReagentCDS · Traditional | Genchem, Inc. | 12/27/2004SE |
| K033056 | Bun Reagent for Beckman Synchron CX & CX Delta ReagentCDS · Traditional | Diamond Diagnostics, Inc. | 01/30/2004SE |
| K925550 | Hi Chem Bun Reagent Kit,Product Number 88806CDS · Traditional | Hichem Diagnostics | 04/20/1993SE |
| K860543 | Blood Urea Nitrogen (Bun) TestcardCDS · Traditional | Ilex Corp. | 04/21/1986SE |
| K855091 | Chem-Pro 1000 Clinical Chemistry-Analysis SysCDS · Traditional | Sen Tech Medical Corp. | 03/14/1986SE |
| K812308 | Lancer Bun Rate Reagent KitCDS · Traditional | Sherwood Medical Co. | 08/31/1981SE |
| K811193 | Bun Rate ReagentCDS · Traditional | Chem-Elec, Inc. | 07/10/1981SE |
| K800616 | Bun Reagent Kit #88108CDS · Traditional | Hi Chem, Inc. | 04/10/1980SE |
| K800590 | Bun KitCDS · Traditional | Nobel Scientific Industries, Inc. | 04/04/1980SE |
| K800071 | Bun Reagent KitCDS · Traditional | Fisher Scientific Co., LLC | 02/05/1980SE |
More from Fisher Scientific Co., LLC
| 510(k) | Device | Decision |
|---|---|---|
| K200107 | epoc Blood Analysis SystemCHL · Special | 06/05/2020SE |
| K113726 | Epoc Chloride Test and Epoc Creatinine TestCGL · Traditional | 10/05/2012SE |
| K093297 | Epoc Bgem, Epoc Reader, Epoc Host, Epoc Care-Fill Capillary TubeKHP · Traditional | 06/09/2010SE |
| K092849 | Blood Collection Tube Samples for Use with Point of Care Blood AnalyzerCEM · Traditional | 03/30/2010SE |
| K090109 | Blood Gas, Electrolyte and Metabolite Test CardCGA · Traditional | 06/24/2009SE |
| K061597 | Epoc Blood Analysis SystemJGS · Traditional | 09/27/2006SE |
Questions and answers
When was epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test cleared by the FDA?
epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test (K171247) received a 510(k) decision of Substantially Equivalent on January 17, 2018, 264 days after the submission was received.
What is the product code of K171247?
The FDA product code is CDS – Electrode, Ion Specific, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.