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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, Indirect Immunofluorescent, Antigen, Control
510(k) Number K811022
Device Name ANA TEST KIT
Applicant
Immuno-Diagnostic Products, Inc.
MD 
Correspondent
Immuno-Diagnostic Products, Inc.
MD 
Regulation Number866.5100
Classification Product Code
DHN  
Date Received04/15/1981
Decision Date 04/23/1981
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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