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) → LFP — Conductivity Rate, Urea Nitrogen

# LFP · Conductivity Rate, 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/LFP

## Overview

- **Product Code:** LFP
- **Device Name:** Conductivity Rate, 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 (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K990039](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LFP/K990039.md) | GAMBRO DQM 200 | Gambro Healthcare | Jan 27, 2000 | SESE |
| [K992847](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LFP/K992847.md) | HICHEM BUN REAGENT | Elan Holdings, Inc. | Oct 14, 1999 | SESE |
| [K963537](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LFP/K963537.md) | SIGMA DIAGNOSTICS BUN REAGENT | Sigma Diagnostics, Inc. | Oct 24, 1996 | SESE |
| [K933679](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LFP/K933679.md) | SIGMA BUN REAGENT | Sigma Chemical Co. | Dec 17, 1993 | SESE |
| [K873132](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LFP/K873132.md) | BUN REAGENT KIT | A-Kem, Inc. | Oct 23, 1987 | SESE |
| [K812945](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LFP/K812945.md) | LIQUILYME BUN REAGENT | Amresco, Inc. | Nov 6, 1981 | SESE |

## Top Applicants

- A-Kem, Inc. — 1 clearance
- Amresco, Inc. — 1 clearance
- Elan Holdings, Inc. — 1 clearance
- Gambro Healthcare — 1 clearance
- Sigma Chemical Co. — 1 clearance

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

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