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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Specimen Collection
510(k) Number K070062
Device Name COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE
Applicant
Diesse Diagnostica Senese S.P.A.
1690 W 38 Place
Unit B1
Hialeah,  FL  33012
Applicant Contact RAUL ALVAREZ
Correspondent
Underwriters Laboratories, Inc.
1285 Walt Whitman Rd.
Melville,  NY  11747
Correspondent Contact JEFFREY D RONGERO
Regulation Number866.2900
Classification Product Code
LIO  
Subsequent Product Code
JTW  
Date Received01/05/2007
Decision Date 07/30/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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