Cleared Traditional

WIENER LAB. URINE STRIP 10 AND 11

K083724 · Wiener Laboratorios Saic · Chemistry

Sep 2009

Decision

261d

Days

Class 2

Risk

About This 510(k) Submission

K083724 is an FDA 510(k) clearance for the WIENER LAB. URINE STRIP 10 AND 11, a Blood, Occult, Colorimetric, In Urine (Class II — Special Controls, product code JIO), submitted by Wiener Laboratorios Saic (Rosario, Santa Fe, AR). The FDA issued a Cleared decision on September 2, 2009, 261 days after receiving the submission on December 15, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.6550.

Submission Details

510(k) Number	K083724 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 15, 2008
Decision Date	September 02, 2009
Days to Decision	261 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF