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FDA 510(k)

AUTION MAX AX-4060 Urinalysis System

K-Number: K193514 · 2023-04-13

ApplicantArkray, Inc.
Decision Date2023-04-13
Product CodeJIL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AUTION MAX AX-4060 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 2023-04-13 under 510(k) number K193514. 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 MAX AX-4060 Urinalysis System?

AUTION MAX AX-4060 Urinalysis System is a medical device that received FDA 510(k) clearance on 2023-04-13. The listed applicant is Arkray, Inc.. The 510(k) number is K193514.

When did AUTION MAX AX-4060 Urinalysis System receive FDA 510(k) clearance?

AUTION MAX AX-4060 Urinalysis System received FDA 510(k) clearance on 2023-04-13, under 510(k) number K193514.

Who is the listed applicant for AUTION MAX AX-4060 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 MAX AX-4060 Urinalysis System?

The FDA product code for AUTION MAX AX-4060 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 SystemK221175Multi-Lancet Device 2, ReliOn Premier Lancing DeviceK200788Assure Titanium Blood Glucose Monitoring SystemK160062AUTION ELEVEN Semi-Automated Urinalysis 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.

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.K171083iChemVELOCITY Automated Urine Chemistry SystemIris Diagnostics, A Division of Iris International, 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.

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