Electrode, Ion Specific, Urea Nitrogen
FDA product code CDS · Class II (moderate risk) · 21 CFR 862.1770 · Clinical Chemistry
15510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Boehringer Mannheim Corp. 1
- Beckman Instruments, Inc. 1
- J.T. Baker Chemical Co. 1
- Fermco Biochemics, Inc. 1
- Fisher Scientific Co., LLC 1
- Nobel Scientific Industries, Inc. 1
- Hi Chem, Inc. 1
- Chem-Elec, Inc. 1
- Sherwood Medical Co. 1
- Sen Tech Medical Corp. 1
- Ilex Corp. 1
- Hichem Diagnostics 1
- Diamond Diagnostics, Inc. 1
- Genchem, Inc. 1
- Epocal, Inc. 1
510(k) clearances
| 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 |
| 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 |
| K791018 | Fermcotest R Bun Rate Reagent Test KitCDS · Traditional | Fermco Biochemics, Inc. | 07/17/1979SE |
| K771060 | Diag. Conducta Rate Bun Reag. SetCDS · Traditional | J.T. Baker Chemical Co. | 07/21/1977SE |
| K761061 | Blood-Urea-Nitrogen (Bun) Analyzer 2CDS · Traditional | Beckman Instruments, Inc. | 01/25/1977SE |
| K760430 | Bun-ReativeCDS · Traditional | Boehringer Mannheim Corp. | 11/01/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0673-2017 Class II | MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b…Incorrect Urea results may be generated sporadically on cobas b 221<6>Roche OMNI S6 system and cannot be… | Roche Diagnostics Operations, Inc. | 10/31/2016Terminated |