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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Epstein-Barr Virus, Other
510(k) Number K881617
Device Name INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY
Applicant
Granbio, Inc.
P.O. Box 892140
Temecula,  CA  92589
Applicant Contact DAVID J GRANLUND
Correspondent
Granbio, Inc.
P.O. Box 892140
Temecula,  CA  92589
Correspondent Contact DAVID J GRANLUND
Regulation Number866.3235
Classification Product Code
LSE  
Date Received04/15/1988
Decision Date 06/07/1988
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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