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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 K851369
Device Name ANTINUCLEAR ANTIBODY TEST KIT
Applicant
Modern Diagnostics, Inc.
5859 Power Inn Rd.
Sacramento,  CA  95824
Applicant Contact VIRGINIA LIPP
Correspondent
Modern Diagnostics, Inc.
5859 Power Inn Rd.
Sacramento,  CA  95824
Correspondent Contact VIRGINIA LIPP
Regulation Number866.5100
Classification Product Code
DHN  
Date Received04/05/1985
Decision Date 05/15/1985
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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