Urea Nitrogen Reagent Set
FDA 510(k) K813415 · Anco Medical Reagents & Assoc.
510(k) numberK813415
Submission
- Device name
- Urea Nitrogen Reagent Set
- Applicant
- Anco Medical Reagents & Assoc.
Mchenry, IL, US - Received
- December 7, 1981
- Decision date
- December 31, 1981
- 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 |
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| K821658 | Hemoglobin ReagentKHG · Traditional | 06/25/1982SE |
| K821526 | Acid Phosphatase Reagent SetCKE · Traditional | 06/10/1982SE |
| K821102 | Megnesium Reagent KitJGJ · Traditional | 05/05/1982SE |
| K820951 | Enzymatic Cholesterol KitCHH · Traditional | 04/26/1982SE |
| K820500 | Total Lipid Reagent SetCFD · Traditional | 03/11/1982SE |
| K820491 | SGPT Reagent SetCKD · Traditional | 03/11/1982SE |
| K820466 | Sgot Reagent SetCIQ · Traditional | 03/11/1982SE |
| K812837 | Alkaline Phosphatase Reagent SetCJL · Traditional | 01/29/1982SE |
Questions and answers
When was Urea Nitrogen Reagent Set cleared by the FDA?
Urea Nitrogen Reagent Set (K813415) received a 510(k) decision of Substantially Equivalent on December 31, 1981, 24 days after the submission was received.
What is the product code of K813415?
The FDA product code is CDW – Diacetyl-Monoxime, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.