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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 K951822
Device Name EBNA ENZYME IMMUNOASSAY KIT
Applicant
Granbio, Inc.
38660 De Portola Rd.
P.O. Box 892140
Temecula,  CA  92589
Applicant Contact DAVID J GRANLUND
Correspondent
Granbio, Inc.
38660 De Portola Rd.
P.O. Box 892140
Temecula,  CA  92589
Correspondent Contact DAVID J GRANLUND
Regulation Number866.3235
Classification Product Code
LLM  
Date Received04/20/1995
Decision Date 02/15/1996
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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