FDA 510(k) Application Details - DEN230036

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN230036
Device Name	Sepsis ImmunoScore
Applicant	Prenosis, Inc. 3440 S Dearborn Street Suite 222S Chicago, IL 60616 US Other 510(k) Applications for this Company
Contact	Bobby Reddy Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SAK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/05/2023
Decision Date	04/02/2024
Decision	DENG -
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review