Blood Urea Nitrogen Bun
FDA 510(k) K771830 · Gamma Enterprises, Inc.
510(k) numberK771830
Submission
- Device name
- Blood Urea Nitrogen Bun
- Applicant
- Gamma Enterprises, Inc.
Mchenry, IL, US - Received
- September 21, 1977
- Decision date
- October 25, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CDW – Diacetyl-Monoxime, Urea Nitrogen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1770
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CDW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K874532 | Blood Urea NitrogenCDW · Traditional | Catachem, Inc. | 01/05/1988SE |
| K871320 | Flow-Pac Urea Nitrogen Reagent Set 2214, 2814CDW · Traditional | American Research Products Co. | 04/22/1987SE |
| K863425 | Amresco Flow Pac Urea Nitrogen Reagents #1346CDW · Traditional | American Research Products Co. | 10/01/1986SE |
| K861775 | Twin Bun/GlucoseCDW · Traditional | Boehringer Mannheim Corp. | 06/27/1986SE |
| K860419 | Urea Nitrogen Reagent SetCDW · Traditional | Sterling Diagnostics, Inc. | 02/11/1986SE |
| K850937 | UreaCDW · Traditional | Dilab, Inc. | 06/10/1985SE |
| K844156 | Urea Nitrogen Reagent SetCDW · Traditional | Livonia Diagnostics, Inc. | 11/13/1984SE |
| K841068 | Urea Nitrogen Reagent SetCDW · Traditional | Medical Specialties, Inc. | 05/01/1984SE |
| K822323 | Ultrachem Bun-Uv, 65080 & 65081CDW · Traditional | Harleco Diagnostics | 09/02/1982SE |
| K821212 | Urea Nitrogen Reagent SetCDW · Traditional | Omega Medical Electronics | 07/22/1982SE |
More from Omega Medical Electronics
| 510(k) | Device | Decision |
|---|---|---|
| K790578 | Gamma Smac ReagentsCIG · Traditional | 05/15/1979SE |
| K780507 | Serum Glutamic-Pyruvic TransaminaseCKC · Traditional | 05/03/1978SE |
| K780506 | Carbon Dioxide ReagentsKMS · Traditional | 05/03/1978SE |
| K780505 | Serum Glutamic-Oxaloacetic-TransaminaseCIT · Traditional | 05/03/1978SE |
| K780504 | Creatine Phosphokinase (CPK)JHS · Traditional | 05/03/1978SE |
| K771843 | Wetting Agents · Traditional | 11/22/1977SE |
| K771836 | Lactate DehydrogenaseCFJ · Traditional | 11/22/1977SE |
| K771832 | ChlorideJFS · Traditional | 11/22/1977SE |
| K771838 | Serum IronJIY · Traditional | 11/03/1977SE |
| K771834 | CreatinineCGX · Traditional | 11/03/1977SE |
Questions and answers
When was Blood Urea Nitrogen Bun cleared by the FDA?
Blood Urea Nitrogen Bun (K771830) received a 510(k) decision of Substantially Equivalent on October 25, 1977, 34 days after the submission was received.
What is the product code of K771830?
The FDA product code is CDW – Diacetyl-Monoxime, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.