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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antinuclear Antibody, Antigen, Control
510(k) Number K885224
Device Name ANA-5 AUTOANTIBODY PROFILE KIT
Applicant
Autoimmunity Diagnostics Corp.
67 Kevin Ave.
Lake Villa,  IL  60046
Applicant Contact CHAPMAN, PHD
Correspondent
Autoimmunity Diagnostics Corp.
67 Kevin Ave.
Lake Villa,  IL  60046
Correspondent Contact CHAPMAN, PHD
Regulation Number866.5100
Classification Product Code
LKJ  
Date Received12/20/1988
Decision Date 04/14/1989
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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