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) → CDS — Electrode, Ion Specific, Urea Nitrogen

# CDS · Electrode, Ion Specific, 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/CDS

## Overview

- **Product Code:** CDS
- **Device Name:** Electrode, Ion Specific, 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 (15 of 15)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K171247](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDS/K171247.md) | epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test | Epocal, Inc. | Jan 17, 2018 | SESE |
| [K040973](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDS/K040973.md) | BUN REAGENT | Genchem, Inc. | Dec 27, 2004 | SESE |
| [K033056](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDS/K033056.md) | BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT | Diamond Diagnostics, Inc. | Jan 30, 2004 | SESE |
| [K925550](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDS/K925550.md) | HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806 | Hichem Diagnostics | Apr 20, 1993 | SESE |
| [K860543](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDS/K860543.md) | BLOOD UREA NITROGEN (BUN) TESTCARD | Ilex Corp. | Apr 21, 1986 | SESE |
| [K855091](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDS/K855091.md) | CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS | Sen Tech Medical Corp. | Mar 14, 1986 | SESE |
| [K812308](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDS/K812308.md) | LANCER BUN RATE REAGENT KIT | Sherwood Medical Co. | Aug 31, 1981 | SESE |
| [K811193](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDS/K811193.md) | BUN RATE REAGENT | Chem-Elec, Inc. | Jul 10, 1981 | SESE |
| [K800616](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDS/K800616.md) | BUN REAGENT KIT #88108 | Hi Chem, Inc. | Apr 10, 1980 | SESE |
| [K800590](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDS/K800590.md) | BUN KIT | Nobel Scientific Industries, Inc. | Apr 4, 1980 | SESE |
| [K800071](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDS/K800071.md) | BUN REAGENT KIT | Fisher Scientific Co., LLC | Feb 5, 1980 | SESE |
| [K791018](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDS/K791018.md) | FERMCOTEST R BUN RATE REAGENT TEST KIT | Fermco Biochemics, Inc. | Jul 17, 1979 | SESE |
| [K771060](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDS/K771060.md) | DIAG. CONDUCTA RATE BUN REAG. SET | J.T. Baker Chemical Co. | Jul 21, 1977 | SESE |
| [K761061](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDS/K761061.md) | BLOOD-UREA-NITROGEN (BUN) ANALYZER 2 | Beckman Instruments, Inc. | Jan 25, 1977 | SESE |
| [K760430](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDS/K760430.md) | BUN-REATIVE | Boehringer Mannheim Corp. | Nov 1, 1976 | SESE |

## Top Applicants

- Beckman Instruments, Inc. — 1 clearance
- Boehringer Mannheim Corp. — 1 clearance
- Chem-Elec, Inc. — 1 clearance
- Diamond Diagnostics, Inc. — 1 clearance
- Epocal, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDS](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDS)

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