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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name blood, occult, colorimetric, in urine
510(k) Number K083724
Device Name WIENER LAB. URINE STRIP 10 AND 11
Applicant
WIENER LABORATORIOS S.A.I.C.
2944 RIOBAMBA
ROSARIO,  AR 2000
Applicant Contact VIVINA CETOLA
Correspondent
WIENER LABORATORIOS S.A.I.C.
2944 RIOBAMBA
ROSARIO,  AR 2000
Correspondent Contact VIVINA CETOLA
Regulation Number864.6550
Classification Product Code
JIO  
Subsequent Product Codes
CDM   CEN   JIL   JIN   JIR  
JJB   JMA   JMT   JRE   LJX  
Date Received12/15/2008
Decision Date 09/02/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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