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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 K023549
Device Name WIENER LAB AMILASA 405 AA LIQUIDA
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 Received10/22/2002
Decision Date 12/09/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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