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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
510(k) Number K150375
Device Name LIAISON VZV IgG, LIAISON Control VZV IgG
Applicant
DiaSorin, Inc.
1951 Northwestern Ave.
Stillwater,  MN  55082
Applicant Contact John Walter
Correspondent
DiaSorin, Inc.
1951 Northwestern Ave.
P.O. Box 285
Stillwater,  MN  55082
Correspondent Contact Sandra Zimniewicz
Regulation Number866.3900
Classification Product Code
LFY  
Subsequent Product Code
JJX  
Date Received02/13/2015
Decision Date 03/11/2015
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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