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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diazo Colorimetry, Bilirubin
510(k) Number K022962
Device Name WIENER LAB. BILIRRUBINA TOTAL AA
Applicant
Wiener Laboratories Saic
2944 Riobamba
Rosario, Santa Fe,  AR 2000
Applicant Contact VIVIANA CETOLA
Correspondent
Wiener Laboratories Saic
2944 Riobamba
Rosario, Santa Fe,  AR 2000
Correspondent Contact VIVIANA CETOLA
Regulation Number862.1110
Classification Product Code
CIG  
Date Received09/06/2002
Decision Date 11/01/2002
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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