FDA 510(k) Application Details - K020566

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	K020566
Device Name	System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Applicant	FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. MALVERN, PA 19355-1307 US Other 510(k) Applications for this Company
Contact	DANIEL J O'SHANNESSY 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	02/20/2002
Decision Date	05/09/2002
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