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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 K072078
Device Name QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307
Applicant
BIOKIT S.A.
CAN MALE S/N
LLICA D'AMUNT
BARCELONA,  ES 08186
Applicant Contact JOAN GUIXER
Correspondent
BIOKIT S.A.
CAN MALE S/N
LLICA D'AMUNT
BARCELONA,  ES 08186
Correspondent Contact JOAN GUIXER
Regulation Number866.5630
Classification Product Code
JZG  
Date Received07/30/2007
Decision Date 12/19/2007
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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