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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Ebv, Capsid
510(k) Number K924091
Device Name EBV-VCA IGG ELISA TEST SYSTEM
Applicant
Zeus Scientific, Inc.
P.O.Box 38
Raritan,  NJ  08869
Applicant Contact JOSEPH A ROSEBROCK
Correspondent
Zeus Scientific, Inc.
P.O.Box 38
Raritan,  NJ  08869
Correspondent Contact JOSEPH A ROSEBROCK
Regulation Number866.3235
Classification Product Code
MCD  
Date Received08/13/1992
Decision Date 01/11/1993
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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