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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 K972145
Device Name HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM
Applicant
Immuno Concepts, Inc.
9779 Business Park Dr.
Suite D
Sacramento,  CA  95827
Applicant Contact ERIC S HOY
Correspondent
Immuno Concepts, Inc.
9779 Business Park Dr.
Suite D
Sacramento,  CA  95827
Correspondent Contact ERIC S HOY
Regulation Number866.5100
Classification Product Code
DHN  
Date Received06/06/1997
Decision Date 02/24/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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