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Systemate Creatinine 67223

by Em Diagnostic Systems, Inc. 510(k)

Active United States

510(k) K843105

Overview

The Systemate Creatinine 67223 is an in vitro diagnostic device classified under alkaline picrate colorimetry for measuring creatinine levels. It operates as a clinical chemistry analyzer designed to quantify creatinine in serum or plasma samples, aiding in the assessment of renal function and detection of conditions such as chronic kidney disease.

This device is supplied as a single-use reagent system and is intended for use in clinical laboratories. It complies with FDA 510(k) clearance (K843105) under the regulatory category 21 CFR 862.1225, with no third-party certification required. The system is not MRI-compatible and must be stored according to manufacturer instructions to maintain stability and performance.

AI-generated from registry data, 18 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 NumberK843105 Date27 Aug 1984ClearedStatusActive

Coverage

1 jurisdiction

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  • 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  • Withdrawn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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