FDA 510(k) Application Details - DEN200072

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN200072
Device Name	Lumipulse G ▀-Amyloid Ratio (1-42/1-40)
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	QSE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/20/2020
Decision Date	05/04/2022
Decision	DENG -
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review