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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 K981812
Device Name EBV-VCA 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
LSE  
Date Received05/22/1998
Decision Date 03/04/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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