Cleared Traditional

URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS

K040703 · Dirui Industrial Co., Ltd. · Chemistry

Aug 2004

Decision

162d

Days

Class 2

Risk

About This 510(k) Submission

K040703 is an FDA 510(k) clearance for the URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS, a Blood, Occult, Colorimetric, In Urine (Class II — Special Controls, product code JIO), submitted by Dirui Industrial Co., Ltd. (Gaithersburg, US). The FDA issued a Cleared decision on August 26, 2004, 162 days after receiving the submission on March 17, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.6550.

Submission Details

510(k) Number	K040703 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 17, 2004
Decision Date	August 26, 2004
Days to Decision	162 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF