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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antiserum, Cf, Epstein-Barr Virus
510(k) Number K981831
Device Name IS EBV-EA-D IGG ELISA TEST SYSTEM
Applicant
Diamedix Corp.
8775 M Centre Park Dr.
#559
Columbia,  MD  21045
Applicant Contact NORMAN JENKINS
Correspondent
Diamedix Corp.
8775 M Centre Park Dr.
#559
Columbia,  MD  21045
Correspondent Contact NORMAN JENKINS
Regulation Number866.3235
Classification Product Code
GNP  
Date Received05/22/1998
Decision Date 02/16/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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