AUTION ELEVEN Semi-Automated Urinalysis System— 510(k) K160062

Name: FDA 510(k) clearance K160062
Creator: U.S. Food and Drug Administration
Published: 2016-10-07

Substantially Equivalent

Arkray, Inc.

FDA 510(k) clearance K160062 for AUTION ELEVEN Semi-Automated Urinalysis System, Substantially Equivalent on 2016-10-07. Applicant: Arkray, Inc.. Device class: 2.

Clearance details

Applicant: Arkray, Inc.
Product code: Code JIL
Device class: Class 2
Regulation: 21 CFR 862.1340
Advisory panel: Clinical Chemistry
Date received: 2016-01-12
Decision date: 2016-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kamigyo-Ku, JP

Download summary PDF View on FDA.gov ↗

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