Direct Urea Nitrogen Test
FDA 510(k) K780262 · Hycel, Inc.
510(k) numberK780262
Submission
- Device name
- Direct Urea Nitrogen Test
- Applicant
- Hycel, Inc.
Mchenry, IL, US - Received
- February 17, 1978
- Decision date
- April 5, 1978
- 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 |
More from Omega Medical Electronics
| 510(k) | Device | Decision |
|---|---|---|
| K802422 | Hycel Trigyceride II Test · Traditional | 10/06/1980SESP |
| K790335 | Hycel MJJF · Traditional | 02/27/1979SE |
| K782176 | Hycel Ldh-Int TestCFH · Traditional | 01/26/1979SE |
| K782116 | Ketosteroid Test, HYCEL-17CCY · Traditional | 01/26/1979SE |
| K782102 | Hycel Counter 211GKL · Traditional | 01/03/1979SE |
| K782101 | Hycel Counter 222GKL · Traditional | 01/03/1979SE |
| K782100 | Hycel Counter 333GKL · Traditional | 01/03/1979SE |
| K781004 | Hma Uric Acid TestKNK · Traditional | 07/27/1978SE |
| K780946 | Royco Model 970 Hematology Data AnalyzerJPJ · Traditional | 07/27/1978SE |
| K780464 | Lelective Kinetic SYSTEM-60JJE · Traditional | 05/03/1978SE |
Questions and answers
When was Direct Urea Nitrogen Test cleared by the FDA?
Direct Urea Nitrogen Test (K780262) received a 510(k) decision of Substantially Equivalent on April 5, 1978, 47 days after the submission was received.
What is the product code of K780262?
The FDA product code is CDW – Diacetyl-Monoxime, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.