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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 K833014
Device Name EBV-VCA-IGM IFA TEST SYSTEM
Applicant
Zeus Scientific, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Zeus Scientific, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.3235
Classification Product Code
LJN  
Date Received09/06/1983
Decision Date 12/27/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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