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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Method, Creatinine
510(k) Number K012065
Device Name WIENER LAB. CREATININA CINETICA AA
Applicant
WIENER LABORATORIES S.A.I.C.
2944 RIOBAMBA
ROSARIO,  AR 2000
Applicant Contact VIVIANA CETOLA
Correspondent
WIENER LABORATORIES S.A.I.C.
2944 RIOBAMBA
ROSARIO,  AR 2000
Correspondent Contact VIVIANA CETOLA
Regulation Number862.1225
Classification Product Code
JFY  
Date Received07/02/2001
Decision Date 10/10/2001
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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