Urea Nitrogen Reagent Set
FDA 510(k) K844156 · Livonia Diagnostics, Inc.
510(k) numberK844156
Submission
- Device name
- Urea Nitrogen Reagent Set
- Applicant
- Livonia Diagnostics, Inc.
Livonia, MI, US - Received
- October 24, 1984
- Decision date
- November 13, 1984
- 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 |
| 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 |
More from Anco Medical Reagents & Assoc.
| 510(k) | Device | Decision |
|---|---|---|
| K852161 | Serum Iron/Vibc Reagent SetJIY · Traditional | 06/10/1985SE |
| K844322 | Sgot Reagent SetCIQ · Traditional | 11/27/1984SE |
| K844283 | SGPT Reagent SetCKD · Traditional | 11/27/1984SE |
| K844237 | Alkaline Phosphatase Reagent SetCIO · Traditional | 11/20/1984SE |
| K844182 | Inorganic Phosphorus Reagent SetCEO · Traditional | 11/09/1984SE |
| K843894 | HDL Precipatating Reagent SetLBR · Traditional | 11/02/1984SE |
| K844075 | Uric Acid Reagent SetLFQ · Traditional | 10/30/1984SE |
| K844024 | Creatinine Reagent SetCGX · Traditional | 10/30/1984SE |
| K843895 | Total Calcium Reagent SetCIC · Traditional | 10/30/1984SE |
| K843893 | Magnesium Reagent SetJGJ · Traditional | 10/30/1984SE |
Questions and answers
When was Urea Nitrogen Reagent Set cleared by the FDA?
Urea Nitrogen Reagent Set (K844156) received a 510(k) decision of Substantially Equivalent on November 13, 1984, 20 days after the submission was received.
What is the product code of K844156?
The FDA product code is CDW – Diacetyl-Monoxime, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.