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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 a medical device manufactured by Arkray, Inc.. It received FDA 510(k) clearance on 2023-04-13 under approval 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. It is manufactured by Arkray, Inc.. The 510(k) number is K193514.

When was AUTION MAX AX-4060 Urinalysis System approved by the FDA?

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

What company makes AUTION MAX AX-4060 Urinalysis System?

AUTION MAX AX-4060 Urinalysis System is manufactured by Arkray, Inc..

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 Devices by Arkray, Inc.

K160062AUTION ELEVEN Semi-Automated Urinalysis System K221175Multi-Lancet Device 2, ReliOn Premier Lancing Device K200788Assure Titanium Blood Glucose Monitoring System K232416AUTION EYE AI-4510 Urine Particle Analysis System

Related Devices (Code: JIL)

K160062AUTION ELEVEN Semi-Automated Urinalysis SystemArkray, Inc. 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.

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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