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Synermed Creatinine Reagent Kit

by Synermed Intl., Inc. 510(k)

Active United States

510(k) K974909

Overview

The Synermed Creatinine Reagent Kit is an in vitro diagnostic reagent for the quantitative measurement of creatinine in serum. It is classified under the device name Alkaline Picrate, Colorimetry, Creatinine and is intended for use in clinical laboratory settings.

The kit is used via manual or automated methods to provide serum creatinine concentration data to healthcare providers to assist in evaluating renal function and diagnosing conditions such as renal impairment. It is supplied as a reagent kit and has received FDA 510(k) clearance under K974909, with a traditional clearance type and substantially equivalent decision.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK974909 Date24 Feb 1998ClearedStatusActive

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

Other devices from Synermed Intl., Inc.

Questions

  • What is the Synermed Creatinine Reagent Kit used for?

    It is used for the quantitative measurement of creatinine in serum to assist healthcare providers in evaluating renal function and diagnosing conditions such as renal impairment, based on the alkaline picrate colorimetry method.

  • How is the Synermed Creatinine Reagent Kit supplied and intended for use?

    It is supplied as a reagent kit and intended for use in clinical laboratory settings via manual or automated methods to provide serum creatinine concentration data.

  • What regulatory pathway was used for the Synermed Creatinine Reagent Kit?

    It received FDA 510(k) clearance under K974909 with a traditional clearance type and a substantially equivalent decision, as indicated in the device data.