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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 K231214
Device Name LIAISON VZV IgG HT, LIAISON Control VZV IgG HT
Applicant
DiaSorin Inc.
1952 Northwestern Avenue
Stillwater,  MN  55082
Applicant Contact Kelly Olien
Correspondent
DiaSorin Inc.
1952 Northwestern Avenue
Stillwater,  MN  55082
Correspondent Contact Kelly Olien
Regulation Number866.3900
Classification Product Code
LFY  
Date Received04/28/2023
Decision Date 10/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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