Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1770](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1770) → CDW — Diacetyl-Monoxime, Urea Nitrogen # CDW · Diacetyl-Monoxime, Urea Nitrogen _Clinical Chemistry · 21 CFR 862.1770 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDW ## Overview - **Product Code:** CDW - **Device Name:** Diacetyl-Monoxime, Urea Nitrogen - **Regulation:** [21 CFR 862.1770](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1770) - **Device Class:** 2 - **Review Panel:** [Clinical Chemistry](/submissions/CH) - **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. ## Recent Cleared Devices (20 of 21) Showing 20 most recent of 21 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K874532](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDW/K874532.md) | BLOOD UREA NITROGEN | Catachem, Inc. | Jan 5, 1988 | SESE | | [K871320](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDW/K871320.md) | FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814 | American Research Products Co. | Apr 22, 1987 | SESE | | [K863425](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDW/K863425.md) | AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346 | American Research Products Co. | Oct 1, 1986 | SESE | | [K861775](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDW/K861775.md) | TWIN BUN/GLUCOSE | Boehringer Mannheim Corp. | Jun 27, 1986 | SESE | | [K860419](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDW/K860419.md) | UREA NITROGEN REAGENT SET | Sterling Diagnostics, Inc. | Feb 11, 1986 | SESE | | [K850937](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDW/K850937.md) | UREA | Dilab, Inc. | Jun 10, 1985 | SESE | | [K844156](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDW/K844156.md) | UREA NITROGEN REAGENT SET | Livonia Diagnostics, Inc. | Nov 13, 1984 | SESE | | [K841068](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDW/K841068.md) | UREA NITROGEN REAGENT SET | Medical Specialties, Inc. | May 1, 1984 | SESE | | [K822323](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDW/K822323.md) | ULTRACHEM BUN-UV, 65080 & 65081 | Harleco Diagnostics | Sep 2, 1982 | SESE | | [K821212](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDW/K821212.md) | UREA NITROGEN REAGENT SET | Omega Medical Electronics | Jul 22, 1982 | SESE | | [K813415](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDW/K813415.md) | UREA NITROGEN REAGENT SET | Anco Medical Reagents & Assoc. | Dec 31, 1981 | SESE | | [K802160](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDW/K802160.md) | BUN COLOR REAGENT & BUN ACID USED | Panmed, Inc. | Oct 10, 1980 | SESE | | [K800673](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDW/K800673.md) | SMAC REPLACEMENT REAGENTS/OF BUN-SERUM | Diagnostic Solutions, Inc. | May 28, 1980 | SESE | | [K781885](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDW/K781885.md) | SERUM, BLOOD UREA NITIOGEN | Fisher Scientific Co., LLC | Dec 20, 1978 | SESE | | [K781305](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDW/K781305.md) | UREA NITROGEN | Analytical & Research Chemicals, Inc. | Aug 31, 1978 | SESE | | [K780262](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDW/K780262.md) | DIRECT UREA NITROGEN TEST | Hycel, Inc. | Apr 5, 1978 | SESE | | [K771830](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDW/K771830.md) | BLOOD UREA NITROGEN BUN | Gamma Enterprises, Inc. | Oct 25, 1977 | SESE | | [K771312](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDW/K771312.md) | BLOOD UREA NITROGEN (BUN) REAGENT | Mallinckrodt Critical Care | Aug 3, 1977 | SESE | | [K771087](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDW/K771087.md) | UNIPAK BUN | Harleco | Jul 21, 1977 | SESE | | [K770470](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDW/K770470.md) | WORTHINGTON BUN | Worthington Biochemical Corp. | Jun 2, 1977 | SESE | ## Top Applicants - American Research Products Co. — 2 clearances - Analytical & Research Chemicals, Inc. — 1 clearance - Anco Medical Reagents & Assoc. — 1 clearance - Boehringer Mannheim Corp. — 1 clearance - Catachem, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDW](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDW) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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