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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 K944449
Device Name EBV-VCA IGM ELISA TEST STSTEM
Applicant
Zeus Scientific, Inc.
200 Evans Way
Branchburg,  NJ  08876
Applicant Contact MARK J KOPNITSKY
Correspondent
Zeus Scientific, Inc.
200 Evans Way
Branchburg,  NJ  08876
Correspondent Contact MARK J KOPNITSKY
Regulation Number866.3235
Classification Product Code
LSE  
Date Received09/12/1994
Decision Date 09/25/1995
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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