Cleared Traditional

K052719 - URITEST 10 URINALYSIS REAGENT STRIPS
(FDA 510(k) Clearance)

K052719 · Arj Medical, Inc. · Chemistry

Dec 2006

Decision

432d

Days

Class 1

Risk

K052719 is an FDA 510(k) clearance for the URITEST 10 URINALYSIS REAGENT STRIPS. This device is classified as a Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.) (Class I — General Controls, product code CDM).

Submitted by Arj Medical, Inc. (Oldsmar, US). The FDA issued a Cleared decision on December 5, 2006, 432 days after receiving the submission on September 29, 2005.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1785.

Submission Details

510(k) Number	K052719 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2005
Decision Date	December 05, 2006
Days to Decision	432 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF