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FDA 510(k)

AUTION ELEVEN Semi-Automated Urinalysis System

K-Number: K160062 · 2016-10-07

ApplicantArkray, Inc.
Decision Date2016-10-07
Product CodeJIL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AUTION ELEVEN Semi-Automated Urinalysis System is a medical device manufactured by Arkray, Inc.. It received FDA 510(k) clearance on 2016-10-07 under approval number K160062. The device is classified under product code JIL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTION ELEVEN Semi-Automated Urinalysis System?

AUTION ELEVEN Semi-Automated Urinalysis System is a medical device that received FDA 510(k) clearance on 2016-10-07. It is manufactured by Arkray, Inc.. The 510(k) number is K160062.

When was AUTION ELEVEN Semi-Automated Urinalysis System approved by the FDA?

AUTION ELEVEN Semi-Automated Urinalysis System received FDA 510(k) clearance on 2016-10-07, under approval number K160062.

What company makes AUTION ELEVEN Semi-Automated Urinalysis System?

AUTION ELEVEN Semi-Automated Urinalysis System is manufactured by Arkray, Inc..

What is the FDA product code for AUTION ELEVEN Semi-Automated Urinalysis System?

The FDA product code for AUTION ELEVEN Semi-Automated Urinalysis System is JIL.

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Related PubMed Literature

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Other Devices by Arkray, Inc.

K221175Multi-Lancet Device 2, ReliOn Premier Lancing Device K200788Assure Titanium Blood Glucose Monitoring System K193514AUTION MAX AX-4060 Urinalysis System K232416AUTION EYE AI-4510 Urine Particle Analysis System

Related Devices (Code: JIL)

K160372URITEK TC-201 URINE CHEMISTRY TEST SYSTEMTeco Diagnostics, Inc. K171083iChemVELOCITY Automated Urine Chemistry SystemIris Diagnostics, A Division of Iris International, Inc. K173327DIP/U.S. Urine Analysis Test SystemHealthy.Io, Ltd. K180356inui In-Home Urine Analysis Test SystemScanadu, Inc. K181024DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent StripsDFI Co., Ltd. K171521DUS R-50S (Urine Chemistry system)DFI Co., Ltd.

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.

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