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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prognostic Test For Development Or Progression Of Preeclampsia
510(k) Number K241453
Device Name Elecsys sFlt-1 and Elecsys PlGF
Applicant
Roche Diagnostics
9115 Hague Road
Indianapolis,  IN  46250
Applicant Contact Jane Phillips
Correspondent
Roche Diagnostics
9115 Hague Road
Indianapolis,  IN  46250
Correspondent Contact Jane Phillips
Classification Product Code
QWH  
Date Received05/22/2024
Decision Date 02/07/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
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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