Cleared Traditional

URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS

K082811 · Urit Medical Electronic Co., Ltd. · Chemistry

Sep 2009

Decision

352d

Days

Class 2

Risk

About This 510(k) Submission

K082811 is an FDA 510(k) clearance for the URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS, a Blood, Occult, Colorimetric, In Urine (Class II — Special Controls, product code JIO), submitted by Urit Medical Electronic Co., Ltd. (Great Neck, US). The FDA issued a Cleared decision on September 11, 2009, 352 days after receiving the submission on September 24, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.6550.

Submission Details

510(k) Number	K082811 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 24, 2008
Decision Date	September 11, 2009
Days to Decision	352 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF