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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 K210254
Device Name MeMed BV
Applicant
MeMed Diagnostics, Ltd.
Nahum Heth 5
Tirat Carmel,  IL 3508504
Applicant Contact Efrat Hartog-David
Correspondent
MeMed Diagnostics, Ltd.
Nahum Heth 5
Tirat Carmel,  IL 3508504
Correspondent Contact Efrat Hartog-David
Regulation Number866.3215
Classification Product Code
QPS  
Date Received01/29/2021
Decision Date 09/01/2021
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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