Skip to content

RAICHEM Urea Nitrogen (Color) Reagent

by Reagents Applications, Inc. 510(k)

Active United States

510(k) K896845

Overview

The RAICHEM Urea Nitrogen (Color) Reagent is a clinical chemistry device used for the measurement of urea nitrogen levels in biological samples. It is designed for use in diagnostic laboratories and is part of the Berthelot Indophenol method for urea nitrogen determination.

The reagent is supplied as a single-use product and is intended for use with compatible clinical chemistry analyzers. It is not sterilized and should be stored according to the manufacturer's instructions. The device is regulated under FDA 510(k) clearance and is classified as a Class II medical device.

AI-generated from registry data, 23 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK896845 Date16 Feb 1990ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

Full name
Raichem(Tm) Urea Nitrogen (Color) Reagent
510(k) Number
FDA Product Code
CDL
Device Class
Class II
Regulation
21 CFR Part 862.1770
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Other devices from Reagents Applications, Inc.

See all devices from Reagents Applications, Inc. →

Questions

  • What is the RAICHEM Urea Nitrogen (Color) Reagent used for?

    This reagent is used in diagnostic laboratories to measure urea nitrogen levels in biological samples, specifically employing the Berthelot Indophenol method.

  • Is the RAICHEM Urea Nitrogen (Color) Reagent sterile?

    No, the reagent is not sterilized and should be stored according to the manufacturer's instructions.

  • How is the RAICHEM Urea Nitrogen (Color) Reagent supplied?

    It is supplied as a single-use product intended for use with compatible clinical chemistry analyzers.

  • What is the regulatory status of the RAICHEM Urea Nitrogen (Color) Reagent?

    The device is regulated under FDA 510(k) clearance and is classified as a Class II medical device.