Cleared Traditional

AUTION EYE AI-4510 Urine Particle Analysis System

K232416 · Arkray, Inc. · Immunology
May 2024
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K232416 is an FDA 510(k) clearance for the AUTION EYE AI-4510 Urine Particle Analysis System, a Counter, Urine Particle (Class II — Special Controls, product code LKM), submitted by Arkray, Inc. (Kyoto, JP). The FDA issued a Cleared decision on May 3, 2024, 266 days after receiving the submission on August 11, 2023. This device falls under the Immunology review panel. Regulated under 21 CFR 864.5200.

Submission Details

510(k) Number K232416 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 2023
Decision Date May 03, 2024
Days to Decision 266 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LKM — Counter, Urine Particle
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5200

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