FDA 510(k) Application Details - K242706

Device Classification Name	More FDA Info for this Device
510(K) Number	K242706
Device Name	Lumipulse G pTau217/▀-Amyloid 1-42 Plasma Ratio
Applicant	Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355 US Other 510(k) Applications for this Company
Contact	Stacey Dolan Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SET Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/09/2024
Decision Date	05/16/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review