Cleared Traditional

COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE

K070062 · Diesse Diagnostica Senese S.P.A. · Microbiology

Jul 2007

Decision

206d

Days

Class 1

Risk

About This 510(k) Submission

K070062 is an FDA 510(k) clearance for the COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE, a Device, Specimen Collection (Class I — General Controls, product code LIO), submitted by Diesse Diagnostica Senese S.P.A. (Hialeah, US). The FDA issued a Cleared decision on July 30, 2007, 206 days after receiving the submission on January 5, 2007. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2900.

Submission Details

510(k) Number	K070062 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 05, 2007
Decision Date	July 30, 2007
Days to Decision	206 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF