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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catalytic Methods, Amylase
510(k) Number K013101
Device Name WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA 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 Number862.1070
Classification Product Code
JFJ  
Date Received09/17/2001
Decision Date 11/16/2001
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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