Diacetyl-Monoxime, Urea Nitrogen
FDA product code CDW · Class II (moderate risk) · 21 CFR 862.1770 · Clinical Chemistry
21510(k) clearances
0PMA approvals
2recalls
Manufacturers
- American Research Products Co. 2
- Anco Medical Reagents & Assoc. 1
- Catachem, Inc. 1
- Boehringer Mannheim Corp. 1
- Sterling Diagnostics, Inc. 1
- Dilab, Inc. 1
- Livonia Diagnostics, Inc. 1
- Medical Specialties, Inc. 1
- Harleco Diagnostics 1
- Omega Medical Electronics 1
- Simmler & Son, Inc. 1
- Panmed, Inc. 1
- Diagnostic Solutions, Inc. 1
- Fisher Scientific Co., LLC 1
- Analytical & Research Chemicals, Inc. 1
- Hycel, Inc. 1
- Gamma Enterprises, Inc. 1
- Mallinckrodt Critical Care 1
- Harleco 1
- Worthington Biochemical Corp. 1
510(k) clearances
| 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 |
| K813415 | Urea Nitrogen Reagent SetCDW · Traditional | Anco Medical Reagents & Assoc. | 12/31/1981SE |
| K802160 | Bun Color Reagent & Bun Acid UsedCDW · Traditional | Panmed, Inc. | 10/10/1980SE |
| K800673 | Smac Replacement Reagents/Of Bun-SerumCDW · Traditional | Diagnostic Solutions, Inc. | 05/28/1980SE |
| K781885 | Serum, Blood Urea NitiogenCDW · Traditional | Fisher Scientific Co., LLC | 12/20/1978SE |
| K781305 | Urea NitrogenCDW · Traditional | Analytical & Research Chemicals, Inc. | 08/31/1978SE |
| K780262 | Direct Urea Nitrogen TestCDW · Traditional | Hycel, Inc. | 04/05/1978SE |
| K771830 | Blood Urea Nitrogen BunCDW · Traditional | Gamma Enterprises, Inc. | 10/25/1977SE |
| K771312 | Blood Urea Nitrogen (Bun) ReagentCDW · Traditional | Mallinckrodt Critical Care | 08/03/1977SE |
| K771087 | Unipak BunCDW · Traditional | Harleco | 07/21/1977SE |
| K770470 | Worthington BunCDW · Traditional | Worthington Biochemical Corp. | 06/02/1977SE |
| K760478 | Reagent, Bun (Urea Nitrogen) Determ.CDW · Traditional | Simmler & Son, Inc. | 10/29/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1385-2021 Class II | Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/Thin 8 mm -…Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload… | Covidien, LP | 03/04/2021Terminated |
| Z-1384-2021 Class II | Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascular 8 mm -…Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload… | Covidien, LP | 03/04/2021Terminated |