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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 the device name listed in this FDA 510(k) record. The listed applicant is Arkray, Inc.. It received FDA 510(k) clearance on 2016-10-07 under 510(k) 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. The listed applicant is Arkray, Inc.. The 510(k) number is K160062.

When did AUTION ELEVEN Semi-Automated Urinalysis System receive FDA 510(k) clearance?

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

Who is the listed applicant for AUTION ELEVEN Semi-Automated Urinalysis System?

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 ELEVEN Semi-Automated Urinalysis System?

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

Other records listing Arkray, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232416AUTION EYE AI-4510 Urine Particle Analysis SystemK193514AUTION MAX AX-4060 Urinalysis SystemK221175Multi-Lancet Device 2, ReliOn Premier Lancing DeviceK200788Assure Titanium Blood Glucose Monitoring System

Related Devices (Code: JIL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K193514AUTION MAX AX-4060 Urinalysis SystemArkray, Inc.K183432cobas u 601 urinalysis test systemRoche DiagnosticsK173327DIP/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

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

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