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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
510(k) Number K771993
Device Name AFT SYSTEM
Applicant
CALBIOCHEM
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
CALBIOCHEM
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number866.5090
Classification Product Code
DBM  
Date Received10/21/1977
Decision Date 11/02/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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