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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alpha-1-Antitrypsin, Antigen, Antiserum, Control
510(k) Number K050596
Device Name QUANTIA A1-AT
Applicant
Biokit, S.A.
Llissa D'Amunt
Barcelona,  ES 08186
Applicant Contact JOAN GUIXER
Correspondent
Biokit, S.A.
Llissa D'Amunt
Barcelona,  ES 08186
Correspondent Contact JOAN GUIXER
Regulation Number866.5130
Classification Product Code
DEM  
Subsequent Product Codes
JJS   JJX  
Date Received03/08/2005
Decision Date 05/13/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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