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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 K973941
Device Name IMMUNOWELL EBNA IGG TEST
Applicant
Genbio
15222 Ave. Of Science
Suite A
San Diego,  CA  92128
Applicant Contact Bryan Kiehl
Correspondent
Genbio
15222 Ave. Of Science
Suite A
San Diego,  CA  92128
Correspondent Contact Bryan Kiehl
Regulation Number866.3235
Classification Product Code
LLM  
Date Received10/15/1997
Decision Date 08/10/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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