Bun Rate Reagent
FDA 510(k) K811193 · Chem-Elec, Inc.
510(k) numberK811193
Submission
- Device name
- Bun Rate Reagent
- Applicant
- Chem-Elec, Inc.
Mchenry, IL, US - Received
- April 30, 1981
- Decision date
- July 10, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| K171247 | epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide TestCDS · Traditional | Epocal, Inc. | 01/17/2018SE |
| 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 |
| 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 |
|---|---|---|
| K943503 | Chemcard Glucose TestCGA · Traditional | 07/23/1996SE |
| K864159 | Solid Phase Deter Serum Cholesterol FR Whole BloodCHH · Traditional | 06/10/1988SE |
| K811406 | Creatinine Rate Reagent KitCGX · Traditional | 08/13/1981SE |
| K811381 | AstraJFL · Traditional | 08/13/1981SE |
| K811319 | Chloride Reagent KitJFS · Traditional | 08/13/1981SE |
| K811165 | Glucose Oxidase Rate ReagentCGA · Traditional | 08/13/1981SE |
| K811310 | Sodium/Potassium Reagent KitsCEM · Traditional | 07/10/1981SE |
| K811701 | Chloride/Carbon Dioxide Rate ReagentJFS · Traditional | 07/01/1981SE |
Questions and answers
When was Bun Rate Reagent cleared by the FDA?
Bun Rate Reagent (K811193) received a 510(k) decision of Substantially Equivalent on July 10, 1981, 71 days after the submission was received.
What is the product code of K811193?
The FDA product code is CDS – Electrode, Ion Specific, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.