510(k) K070062

COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE by Diesse Diagnostica Senese S.P.A. — Product Code LIO

K070062 is an FDA 510(k) premarket notification submitted by Diesse Diagnostica Senese S.P.A. for the device "COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE". The FDA issued a decision of Substantially Equivalent on July 30, 2007. The device falls under product code LIO (Device, Specimen Collection), a Class I device regulated under 21 CFR 866.2900. Diesse Diagnostica Senese S.P.A. has at least 1 other 510(k) clearance on record.