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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antibody Igm, If, Epstein-Barr Virus
510(k) Number K991459
Device Name COPALIS EBV-M ANTIBODY ASSAY
Applicant
DiaSorin, Inc.
9175 Guiford Rd.
Columbia,  MD  21046
Applicant Contact JUDITH J SMITH
Correspondent
Tuv Product Service, Inc.
1775 Old Hwy. 8
New Brighton,  MN  55112
Regulation Number866.3235
Classification Product Code
LJN  
Date Received04/26/1999
Decision Date 05/14/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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