Cleared Traditional

AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL

K121456 · Arkray, Inc. · Chemistry
Feb 2013
Decision
261d
Days
Class 1
Risk

About This 510(k) Submission

K121456 is an FDA 510(k) clearance for the AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL, a Automated Urinalysis System (Class I — General Controls, product code KQO), submitted by Arkray, Inc. (Edina, US). The FDA issued a Cleared decision on February 1, 2013, 261 days after receiving the submission on May 16, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2900.

Submission Details

510(k) Number K121456 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2012
Decision Date February 01, 2013
Days to Decision 261 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code KQO — Automated Urinalysis System
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2900

Similar Devices — KQO Automated Urinalysis System

All 45
URISCAN OPTIMA
K141874 · Yd Diagnostics Corp. · May 2015
Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control
K142543 · ACON Laboratories, Inc. · May 2015
CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT
K140717 · Siemens Healthcare Diagnostics · Nov 2014
CYBOW READER, MODELS 300 & 720
K102188 · DFI Co., Ltd. · Aug 2011
CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT
K101852 · Iris International Inc., A Division of Iris Iris I · Mar 2011
URITEST 50 AND URITEST 500 URINE ANALYZER
K091472 · Arj Medical, Inc. · Apr 2010