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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 K983804
Device Name THE APTUS (AUTOMATED) APPLICATION OF THE EBV-EA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
Applicant
Zeus Scientific, Inc.
P.O.Box 38
Raritan,  NJ  08869
Applicant Contact MARK J KOPNITSKY
Correspondent
Zeus Scientific, Inc.
P.O.Box 38
Raritan,  NJ  08869
Correspondent Contact MARK J KOPNITSKY
Regulation Number866.3235
Classification Product Code
LSE  
Date Received10/28/1998
Decision Date 12/08/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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