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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 K926114
Device Name HEP-2 ANTINUCLEAR ANTIBODY TEST SYSTEM
Applicant
Tissue Culture Biotec, Inc.
910 Technology Blvd.
Suite C
Bozeman,  MT  59715
Applicant Contact PETER NAPTHINE
Correspondent
Tissue Culture Biotec, Inc.
910 Technology Blvd.
Suite C
Bozeman,  MT  59715
Correspondent Contact PETER NAPTHINE
Regulation Number866.5100
Classification Product Code
DHN  
Date Received12/03/1992
Decision Date 05/20/1993
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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