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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunoassay For Host Biomarkers Of Infection
510(k) Number K213936
Device Name LIAISON MeMed BV, LIAISON MeMed BV Control Set
Applicant
Diasorin, Inc.
1951 Northwestern Ave.
Stillwater,,  MN  55082 -0285
Applicant Contact John C. Walter
Correspondent
Diasorin, Inc.
1951 Northwestern Ave.
Stillwater,,  MN  55082 -0285
Correspondent Contact Emily Peterson
Regulation Number866.3215
Classification Product Code
QPS  
Subsequent Product Code
QCH  
Date Received12/16/2021
Decision Date 07/14/2022
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
Predetermined Change
Control Plan Authorized		 No
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