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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name prognostic test for development or progression of preeclampsia
De Novo Number DEN220027
Device Name B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System
Requester
brahms gmbh, part of thermo fisher scientific
neuensdorfstrasse 25
hennigsdorf,  DE 16761
Contact anja jagalla
Regulation Number862.1602
Classification Product Code
QWH  
Date Received05/02/2022
Decision Date 05/18/2023
Decision granted (DENG)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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