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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 K162961
Device Name LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set
Applicant
DiaSorin, Inc.
1951 Northwestern Ave.
Stillwater,,  MN  55082 -0285
Applicant Contact JOHN WALTER
Correspondent
DiaSorin, Inc.
1951 Northwestern Ave.
Stillwater,,  MN  55082 -0285
Correspondent Contact JOHN C. WALTER
Regulation Number866.3235
Classification Product Code
LSE  
Subsequent Product Codes
JJX   LLM  
Date Received10/24/2016
Decision Date 01/05/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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