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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 K230944
Device Name MeMed BV
Applicant
MeMed Diagnostics, Ltd.
Nahum Het 7
Tirat Carmel,  IL 3508506
Applicant Contact Efrat Hartog-David
Correspondent
MeMed Diagnostics, Ltd.
Nahum Het 7
Tirat Carmel,  IL 3508506
Correspondent Contact Efrat Hartog-David
Regulation Number866.3215
Classification Product Code
QPS  
Date Received04/04/2023
Decision Date 06/30/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT05439551
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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