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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2007
Date Received
January 5, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Device, Specimen Collection
Device Class
Class I
Regulation Number
866.2900
Review Panel
MI
Submission Type