Diacetyl-Monoxime, Urea Nitrogen
The Diacetyl-Monoxime Urea Nitrogen Test is a clinical chemistry device that measures blood urea nitrogen (BUN) using the colorimetric reaction of urea with diacetyl monoxime under acidic conditions, producing a yellow-colored complex quantified spectrophotometrically, used in the assessment of kidney function. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CDW, regulated under 21 CFR 862.1770, within the Clinical Chemistry medical specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- CDW
- Device Class
- FDA class 2
- Regulation Number
- 862.1770
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 21 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K874532 | BLOOD UREA NITROGEN | Jan 05, 1988 | Substantially Equivalent | Catachem, Inc. |
| K871320 | FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814 | Apr 22, 1987 | Substantially Equivalent | American Research Products Co. |
| K863425 | AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346 | Oct 01, 1986 | Substantially Equivalent | American Research Products Co. |
| K861775 | TWIN BUN/GLUCOSE | Jun 27, 1986 | Substantially Equivalent | Boehringer Mannheim Corp. |
| K860419 | UREA NITROGEN REAGENT SET | Feb 11, 1986 | Substantially Equivalent | Sterling Diagnostics, Inc. |
| K850937 | UREA | Jun 10, 1985 | Substantially Equivalent | Dilab, Inc. |
| K844156 | UREA NITROGEN REAGENT SET | Nov 13, 1984 | Substantially Equivalent | Livonia Diagnostics, Inc. |
| K841068 | UREA NITROGEN REAGENT SET | May 01, 1984 | Substantially Equivalent | Medical Specialties, Inc. |
| K822323 | ULTRACHEM BUN-UV, 65080 & 65081 | Sep 02, 1982 | Substantially Equivalent | Harleco Diagnostics |
| K821212 | UREA NITROGEN REAGENT SET | Jul 22, 1982 | Substantially Equivalent | Omega Medical Electronics |
| K813415 | UREA NITROGEN REAGENT SET | Dec 31, 1981 | Substantially Equivalent | Anco Medical Reagents & Assoc. |
| K802160 | BUN COLOR REAGENT & BUN ACID USED | Oct 10, 1980 | Substantially Equivalent | Panmed, Inc. |
| K800673 | SMAC REPLACEMENT REAGENTS/OF BUN-SERUM | May 28, 1980 | Substantially Equivalent | Diagnostic Solutions, Inc. |
| K781885 | SERUM, BLOOD UREA NITIOGEN | Dec 20, 1978 | Substantially Equivalent | Fisher Scientific Co., LLC |
| K781305 | UREA NITROGEN | Aug 31, 1978 | Substantially Equivalent | Analytical & Research Chemicals, Inc. |
| K780262 | DIRECT UREA NITROGEN TEST | Apr 05, 1978 | Substantially Equivalent | Hycel, Inc. |
| K771830 | BLOOD UREA NITROGEN BUN | Oct 25, 1977 | Substantially Equivalent | Gamma Enterprises, Inc. |
| K771312 | BLOOD UREA NITROGEN (BUN) REAGENT | Aug 03, 1977 | Substantially Equivalent | Mallinckrodt Critical Care |
| K771087 | UNIPAK BUN | Jul 21, 1977 | Substantially Equivalent | Harleco |
| K770470 | WORTHINGTON BUN | Jun 02, 1977 | Substantially Equivalent | Worthington Biochemical Corp. |
| K760478 | REAGENT, BUN (UREA NITROGEN) DETERM. | Oct 29, 1976 | Substantially Equivalent | Simmler & Son, Inc. |