FDA 510(k) Application Details - K100375

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	K100375
Device Name	System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Applicant	Siemens Healthcare Diagnostics Inc. PO BOX 6101 M/S 514 NEWARK, DE 19714-6101 US Other 510(k) Applications for this Company
Contact	PAMELA JURGA 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	02/12/2010
Decision Date	04/06/2011
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