FDA 510(k) Application Details - DEN190056

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN190056
Device Name	ADVIA Centaur Enhanced Liver Fibrosis (ELF)
Applicant	Siemens Healthcare Diagnostics Inc. 511 Benedict Ave Tarrytown, NY 10591 US Other 510(k) Applications for this Company
Contact	Matthew Gee Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QQB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/26/2019
Decision Date	08/20/2021
Decision	DENG -
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review