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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, test, beta-2-microglobulin immunological
510(k) Number K050613
Device Name QUANTIA BETA-2 MICROGLOBULIN
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 Number866.5630
Classification Product Code
JZG  
Subsequent Product Codes
JJS   JJX  
Date Received03/10/2005
Decision Date 08/16/2005
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
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