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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antibody Igm, If, Epstein-Barr Virus
510(k) Number K864604
Device Name EBV VCA IGM ANTIBODY ASSAY KIT
Applicant
Granbio, Inc.
P.O. Box 892140
Temecula,  CA  92589
Applicant Contact GRANLUND, PHD
Correspondent
Granbio, Inc.
P.O. Box 892140
Temecula,  CA  92589
Correspondent Contact GRANLUND, PHD
Regulation Number866.3235
Classification Product Code
LJN  
Date Received11/24/1986
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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