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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Antigen, Nuclear, Epstein-Barr Virus
510(k) Number K895708
Device Name EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI)
Applicant
Immuno Concepts, Inc.
9779-D Business Park Dr.
Sacramento,  CA  95827
Applicant Contact DON W VALENCIA
Correspondent
Immuno Concepts, Inc.
9779-D Business Park Dr.
Sacramento,  CA  95827
Correspondent Contact DON W VALENCIA
Regulation Number866.3235
Classification Product Code
LLM  
Date Received09/25/1989
Decision Date 12/11/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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