Bun Reagent
FDA 510(k) K040973 · Genchem, Inc.
510(k) numberK040973
Submission
- Device name
- Bun Reagent
- Applicant
- Genchem, Inc.
Brea, CA, US - Received
- April 14, 2004
- Decision date
- December 27, 2004
- 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 |
|---|---|---|---|
| K171247 | epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide TestCDS · Traditional | Epocal, Inc. | 01/17/2018SE |
| 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 |
|---|---|---|
| K090283 | Calibrator 1,2, and 3 Models: GEN-CAL1, GEN-CAL2, and GEN-CAL3JIX · Abbreviated | 06/05/2009SE |
| K040977 | Genchem Electrolyte BufferJGS · Traditional | 12/27/2004SE |
| K040976 | Genchem Creatinine ReagentCGX · Traditional | 12/27/2004SE |
| K040975 | Genchem CO2 Acid ReagentJFL · Traditional | 12/27/2004SE |
| K040974 | Glucose Oxidase, GlucoseCGA · Traditional | 12/27/2004SE |
| K040972 | Calcium, Azo Dye ReagentCJY · Traditional | 12/27/2004SE |
| K040971 | Genchem Ise Electrolyte ReferenceJGS · Traditional | 12/22/2004SE |
Questions and answers
When was Bun Reagent cleared by the FDA?
Bun Reagent (K040973) received a 510(k) decision of Substantially Equivalent on December 27, 2004, 257 days after the submission was received.
What is the product code of K040973?
The FDA product code is CDS – Electrode, Ion Specific, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.