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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Uric, Uricase (Colorimetric)
510(k) Number K023550
Device Name WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA
Applicant
WIENER LABORATORIES S.A.I.C.
2944 RIOBAMBA
ROSARIO, SANTA FE,  AR 2000
Applicant Contact VIVIANA CETOLA
Correspondent
WIENER LABORATORIES S.A.I.C.
2944 RIOBAMBA
ROSARIO, SANTA FE,  AR 2000
Correspondent Contact VIVIANA CETOLA
Regulation Number862.1775
Classification Product Code
KNK  
Date Received10/22/2002
Decision Date 12/09/2002
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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