FDA 510(k) Application Details - K191973

Device Classification Name	System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer   More FDA Info for this Device
510(K) Number	K191973
Device Name	System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Applicant	Fujirebio Dianostics, Inc. 201 Great Valley Parkway Malvern, PA 19355 US Other 510(k) Applications for this Company
Contact	Kristin Maddaloni Other 510(k) Applications for this Contact
Regulation Number	866.6010   More FDA Info for this Regulation Number
Classification Product Code	NIG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/24/2019
Decision Date	10/22/2019
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