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Kinetic Creatinine

by American Monitor Corp.

510(k) K830447

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK830447 Date24 Mar 1983ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Kinetic Creatinine is a Creatinine Measurement Device (Colorimetry, Alkaline Picrate) designed to quantify creatinine levels in plasma and urine. It employs kinetic colorimetric analysis to provide accurate measurements, supporting clinical assessments of renal function and dialysis monitoring.

This device is intended for in vitro diagnostic use in clinical chemistry laboratories. Supplied as a single-use reagent system, it requires no sterilisation beyond manufacturer-provided packaging. Authorised under FDA 510(k) clearance (K830447) as substantially equivalent, it adheres to regulation 862.1225 and is classified as Class II. Storage conditions and shelf life are specified in the accompanying instructions.

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