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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 K802527
Device Name TEST KIT FOR DETECTION OF ANTINUCLEAR
Applicant
Bartels & Stout, Inc.
P.O. Box 3093
Bellevue ,  WA  98009
Applicant Contact KEVIN T MCGOURTY
Correspondent
Bartels & Stout, Inc.
P.O. Box 3093
Bellevue ,  WA  98009
Correspondent Contact KEVIN T MCGOURTY
Regulation Number866.5100
Classification Product Code
DHN  
Date Received10/15/1980
Decision Date 01/05/1981
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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