FDA 510(k) Application Details - K241453

Device Classification Name	More FDA Info for this Device
510(K) Number	K241453
Device Name	Elecsys sFlt-1 and Elecsys PlGF
Applicant	Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 US Other 510(k) Applications for this Company
Contact	Jane Phillips Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QWH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/22/2024
Decision Date	02/07/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review