Cleared Traditional

AUTION ELEVEN Semi-Automated Urinalysis System

K160062 · Arkray, Inc. · Chemistry
Oct 2016
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K160062 is an FDA 510(k) clearance for the AUTION ELEVEN Semi-Automated Urinalysis System, a Method, Enzymatic, Glucose (urinary, Non-quantitative) (Class II — Special Controls, product code JIL), submitted by Arkray, Inc. (Kamigyo-Ku, JP). The FDA issued a Cleared decision on October 7, 2016, 269 days after receiving the submission on January 12, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1340.

Submission Details

510(k) Number K160062 FDA.gov
FDA Decision Cleared SESE
Date Received January 12, 2016
Decision Date October 07, 2016
Days to Decision 269 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIL — Method, Enzymatic, Glucose (urinary, Non-quantitative)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1340

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