AUTION MAX AX-4060 Urinalysis System— 510(k) K193514

Substantially Equivalent

Arkray, Inc.

FDA 510(k) clearance K193514 for AUTION MAX AX-4060 Urinalysis System, Substantially Equivalent on 2023-04-13. Applicant: Arkray, Inc..

Clearance details

Applicant: Arkray, Inc.
Product code: Code JIL
Advisory panel: Clinical Chemistry
Date received: 2019-12-19
Decision date: 2023-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kamigyo-Ku, JP

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