Urea Nitrogen (Enzymatic) Determination
FDA 510(k) K822154 · The Dow Chemical Co.
510(k) numberK822154
Submission
- Device name
- Urea Nitrogen (Enzymatic) Determination
- Applicant
- The Dow Chemical Co.
Mchenry, IL, US - Received
- July 23, 1982
- Decision date
- August 5, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CDN – Urease, Photometric, Urea Nitrogen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1770
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| K190326 | VITROS XT Chemistry Products UREA-CREA SlidesCDN · Traditional | Ortho-Clinical Diagnostics, Inc. | 03/14/2019SE |
| K132462 | S Test Reagent Cartridge Bun and S Test Reagent Cartridge CreCDN · Traditional | Hitachi Chemical Diagnostics, Inc. | 10/28/2013SE |
| K123322 | Ace Bun/Urea Reagent, Ace Creatinine Reagent, Ace Uric Acid Reagent, Ace CK ReagentCDN · Traditional | Alfa Wassermann Diagnostics Technologies, LLC | 05/21/2013SE |
| K113389 | Ace CK Reagent,Ace Bun/Urea Reagent,Ace Uric Acid Reagent,Ace Creatinine ReagentCDN · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 08/10/2012SE |
| K103615 | Ace Urea Nitrogen Reagent, Calcium-Arseazo Reagent, Creatinine Reagent, Inorganic…CDN · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 09/08/2011SE |
| K001885 | Vitros Chemistry Products Bun/Urea Slides and Vitros Chemistry Products Calibrator Kit 1CDN · Special | Ortho-Clinical Diagnostics, Inc. | 07/20/2000SE |
| K972012 | Cholestech Bun/Creatinine Test SystemCDN · Traditional | Cholestech Corp. | 07/24/1997SE |
| K961196 | Ektachem Clinical Chemistry Urea Nitrogen/Urea (Bun/Urea)CDN · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 05/15/1996SE |
| K943042 | Bun QvetCDN · Traditional | Prisma Systems | 12/29/1994SE |
| K922969 | King Diagnostics Urea Nitrogen ReagentCDN · Traditional | King Diagnostics, Inc. | 10/13/1992SE |
More from King Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K823474 | Enzymatic Glucose DeterminationCGA · Traditional | 12/30/1982SE |
| K821536 | Dowflow Alt-Uv DeterminationCKA · Traditional | 06/14/1982SE |
| K821315 | Dowflow Enzymatic Triglycerides DetermCDT · Traditional | 05/24/1982SE |
| K820714 | Dow Bilirubin(Direct) DeterminationCIG · Traditional | 04/01/1982SE |
| K820675 | Bilirubin(Total) Determination CTMSCIG · Traditional | 04/01/1982SE |
| K812777 | Direct Iron Reagent SetJIY · Traditional | 10/19/1981SE |
| K811806 | Quick-Chem ColorimeterJJQ · Traditional | 07/15/1981SE |
| K810861 | Creatine Kinase MB Isoenzyme Immuno UVJHW · Traditional | 04/14/1981SE |
| K810727 | Ast-Uv (Plp-Activated) DeterminationCIT · Traditional | 03/31/1981SE |
| K801501 | UV Uric Acid StandardsJIS · Traditional | 09/26/1980SE |
Questions and answers
When was Urea Nitrogen (Enzymatic) Determination cleared by the FDA?
Urea Nitrogen (Enzymatic) Determination (K822154) received a 510(k) decision of Substantially Equivalent on August 5, 1982, 13 days after the submission was received.
What is the product code of K822154?
The FDA product code is CDN – Urease, Photometric, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.