AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM - Aution Hybrid Au-4050 Fully Automated Integrated Urine Analyzer System

• • Terminated Z-1850-2019 FDA Class II ·initiated 3 May 2019

  This correction is being initiated due to a software issue which results in the possibility of incorrect patient information being assigned to sample results when the following rare combination of three specific events were to occur: 1) No measurement results are generated due to an error by a urine sediment measurement. 2) The instrument is shutdown incorrectly. 3) An item rack is used for subsequent sample measurements.

510(k) Number

K121456 ↗

FDA Product Code

KQO

Models / Variants

Aution Hybrid Au-4050 Fully Automated Integrated Urine Analyzer System

Uriflet S 9HA Urine Test Strips

Aution Control

Device Class

Class I

Regulation

21 CFR Part 862.2900

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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