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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K030482
Device Name WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553
Applicant
Wiener Laboratories
2944 Riobamba
Rosario, Santa Fe,  AR 2000
Applicant Contact VIVIANA CETOLA
Correspondent
Wiener Laboratories
2944 Riobamba
Rosario, Santa Fe,  AR 2000
Correspondent Contact VIVIANA CETOLA
Regulation Number862.1660
Classification Product Code
JJY  
Date Received02/13/2003
Decision Date 03/19/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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