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Raichem Creatinine Reagent

by Reagents Applications, Inc. 510(k)

Active United States

510(k) K840872

Overview

This is an alkaline picrate, colorimetry device for creatinine measurement. It is substantially equivalent to a legally marketed predicate device and classified under device class 2 with product code CGX.

It is supplied by Reagents Applications, Inc. and holds FDA 510(k) clearance K840872, granted on April 18, 1984. The device is used in clinical chemistry settings for in vitro diagnostic testing.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK840872 Date18 Apr 1984ClearedStatusActive

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 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
CGX
Device Class
Class II
Regulation
21 CFR Part 862.1225
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the RAICHEM CREATININE REAGENT used for?

    The RAICHEM CREATININE REAGENT is an alkaline picrate, colorimetry device designed for creatinine measurement in clinical chemistry settings, used for in vitro diagnostic testing of creatinine levels in patient samples.

  • How is the RAICHEM CREATININE REAGENT supplied and by whom?

    The device is supplied by Reagents Applications, Inc. as an alkaline picrate colorimetry reagent for creatinine testing, provided in a format suitable for use in clinical laboratory analyzers or manual procedures as part of in vitro diagnostic workflows.

  • Is the RAICHEM CREATININE REAGENT sterile or single-use?

    The device data does not specify sterility or single-use status; as an in vitro diagnostic reagent for creatinine measurement, it is intended for use in controlled laboratory environments where reagent stability and contamination control are managed per manufacturer instructions and laboratory protocols.

  • What regulatory clearance does the RAICHEM CREATININE REAGENT have?

    The RAICHEM CREATININE REAGENT holds FDA 510(k) clearance K840872, granted on April 18, 1984, confirming it is substantially equivalent to a legally marketed predicate device and classified under device class 2 with product code CGX for alkaline picrate, colorimetry creatinine measurement.