Cleared Special

AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM

K093098 · Arkray, Inc. · Chemistry
Dec 2009
Decision
83d
Days
Class 1
Risk

About This 510(k) Submission

K093098 is an FDA 510(k) clearance for the AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM, a Automated Urinalysis System (Class I — General Controls, product code KQO), submitted by Arkray, Inc. (Richardson, US). The FDA issued a Cleared decision on December 23, 2009, 83 days after receiving the submission on October 1, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2900.

Submission Details

510(k) Number K093098 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 2009
Decision Date December 23, 2009
Days to Decision 83 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code KQO — Automated Urinalysis System
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2900

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