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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antiserum, Cf, Epstein-Barr Virus
510(k) Number K864347
Device Name INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA
Applicant
Granbio, Inc.
P.O. Box 892140
Temecula,  CA  92589
Applicant Contact DAVID GRANLUND
Correspondent
Granbio, Inc.
P.O. Box 892140
Temecula,  CA  92589
Correspondent Contact DAVID GRANLUND
Regulation Number866.3235
Classification Product Code
GNP  
Date Received11/04/1986
Decision Date 02/02/1987
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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