CDW · Diacetyl-Monoxime, Urea Nitrogen
Clinical Chemistry · 21 CFR 862.1770 · Class 2
Overview
| Product Code | CDW |
|---|---|
| Device Name | Diacetyl-Monoxime, Urea Nitrogen |
| Regulation | 21 CFR 862.1770 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.
Classification Rationale
Class II.
Cleared Devices (21)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K874532 | BLOOD UREA NITROGEN | Catachem, Inc. | Jan 5, 1988 | SESE |
| K871320 | FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814 | American Research Products Co. | Apr 22, 1987 | SESE |
| K863425 | AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346 | American Research Products Co. | Oct 1, 1986 | SESE |
| K861775 | TWIN BUN/GLUCOSE | Boehringer Mannheim Corp. | Jun 27, 1986 | SESE |
| K860419 | UREA NITROGEN REAGENT SET | Sterling Diagnostics, Inc. | Feb 11, 1986 | SESE |
| K850937 | UREA | Dilab, Inc. | Jun 10, 1985 | SESE |
| K844156 | UREA NITROGEN REAGENT SET | Livonia Diagnostics, Inc. | Nov 13, 1984 | SESE |
| K841068 | UREA NITROGEN REAGENT SET | Medical Specialties, Inc. | May 1, 1984 | SESE |
| K822323 | ULTRACHEM BUN-UV, 65080 & 65081 | Harleco Diagnostics | Sep 2, 1982 | SESE |
| K821212 | UREA NITROGEN REAGENT SET | Omega Medical Electronics | Jul 22, 1982 | SESE |
| K813415 | UREA NITROGEN REAGENT SET | Anco Medical Reagents & Assoc. | Dec 31, 1981 | SESE |
| K802160 | BUN COLOR REAGENT & BUN ACID USED | Panmed, Inc. | Oct 10, 1980 | SESE |
| K800673 | SMAC REPLACEMENT REAGENTS/OF BUN-SERUM | Diagnostic Solutions, Inc. | May 28, 1980 | SESE |
| K781885 | SERUM, BLOOD UREA NITIOGEN | Fisher Scientific Co., LLC | Dec 20, 1978 | SESE |
| K781305 | UREA NITROGEN | Analytical & Research Chemicals, Inc. | Aug 31, 1978 | SESE |
| K780262 | DIRECT UREA NITROGEN TEST | Hycel, Inc. | Apr 5, 1978 | SESE |
| K771830 | BLOOD UREA NITROGEN BUN | Gamma Enterprises, Inc. | Oct 25, 1977 | SESE |
| K771312 | BLOOD UREA NITROGEN (BUN) REAGENT | Mallinckrodt Critical Care | Aug 3, 1977 | SESE |
| K771087 | UNIPAK BUN | Harleco | Jul 21, 1977 | SESE |
| K770470 | WORTHINGTON BUN | Worthington Biochemical Corp. | Jun 2, 1977 | SESE |
| K760478 | REAGENT, BUN (UREA NITROGEN) DETERM. | Simmler & Son, Inc. | Oct 29, 1976 | SESE |
Top Applicants
- American Research Products Co. — 2 clearances
- Worthington Biochemical Corp. — 1 clearance
- Sterling Diagnostics, Inc. — 1 clearance
- Simmler & Son, Inc. — 1 clearance
- Panmed, Inc. — 1 clearance
