FDA 510(k)

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

K-Number: K121456 · 2013-02-01

Decision Date2013-02-01

Product CodeKQO

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Arkray, Inc.. It received FDA 510(k) clearance on 2013-02-01 under 510(k) number K121456. The device is classified under product code KQO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL is a medical device that received FDA 510(k) clearance on 2013-02-01. The listed applicant is Arkray, Inc.. The 510(k) number is K121456.

When did AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL receive FDA 510(k) clearance?

AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL received FDA 510(k) clearance on 2013-02-01, under 510(k) number K121456.

Who is the listed applicant for AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL?

The FDA 510(k) record lists Arkray, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL?

The FDA product code for AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL is KQO.

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Other records listing Arkray, Inc. as applicant

K232416AUTION EYE AI-4510 Urine Particle Analysis System K193514AUTION MAX AX-4060 Urinalysis System K221175Multi-Lancet Device 2, ReliOn Premier Lancing Device K200788Assure Titanium Blood Glucose Monitoring System K160062AUTION ELEVEN Semi-Automated Urinalysis System K093098AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM

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Related Devices (Code: KQO)

K102188CYBOW READER, MODELS 300 & 720DFI Co., Ltd.K101852CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KITIris International Inc., A Division of Iris Iris I K091472URITEST 50 AND URITEST 500 URINE ANALYZERArj Medical, Inc.K093555COBAS U411 TEST SYSTEMRoche Diagnostics K093098AUTION MAX MODEL AX-4030 URINALYSIS SYSTEMArkray, Inc.K070929ACON U120 URINE ANALYZER, MODEL U111-101ACON Laboratories, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.