Cleared Traditional

URITEST 50 AND URITEST 500 URINE ANALYZER

K091472 · Arj Medical, Inc. · Chemistry
Apr 2010
Decision
344d
Days
Class 1
Risk

About This 510(k) Submission

K091472 is an FDA 510(k) clearance for the URITEST 50 AND URITEST 500 URINE ANALYZER, a Automated Urinalysis System (Class I — General Controls, product code KQO), submitted by Arj Medical, Inc. (Oldsmar, US). The FDA issued a Cleared decision on April 27, 2010, 344 days after receiving the submission on May 18, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2900.

Submission Details

510(k) Number K091472 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 2009
Decision Date April 27, 2010
Days to Decision 344 days
Submission Type Traditional
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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