AUTION EYE AI-4510 Urine Particle Analysis System— 510(k) K232416

Substantially Equivalent

Arkray, Inc.

FDA 510(k) clearance K232416 for AUTION EYE AI-4510 Urine Particle Analysis System, Substantially Equivalent on 2024-05-03. Applicant: Arkray, Inc..

Clearance details

Applicant: Arkray, Inc.
Product code: Code LKM
Advisory panel: Hematology
Date received: 2023-08-11
Decision date: 2024-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kyoto, JP

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