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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 K760155
Device Name TEST, (IVDP) MITOCHONDRIAL ANTIBODY
Applicant
ZEUS SCIENTIFIC, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ZEUS SCIENTIFIC, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number866.5090
Classification Product Code
DBM  
Date Received07/02/1976
Decision Date 07/20/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
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