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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 K933251
Device Name EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST
Applicant
Virion (U.S.), Inc.
4 Upperfield Rd.
Morristown,  NJ  07960
Applicant Contact WILLIAM J HAUSLER, JR., PH.D
Correspondent
Virion (U.S.), Inc.
4 Upperfield Rd.
Morristown,  NJ  07960
Correspondent Contact WILLIAM J HAUSLER, JR., PH.D
Regulation Number866.3235
Classification Product Code
MCD  
Date Received07/02/1993
Decision Date 06/13/1994
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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