FDA 510(k) Application Details - K091916

Device Classification Name	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K091916
Device Name	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Applicant	SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE PO BOX 6101 NEWARK, DE 19714-6101 US Other 510(k) Applications for this Company
Contact	KATHLEEN ANN DRAY-LYONS Other 510(k) Applications for this Contact
Regulation Number	864.7320   More FDA Info for this Regulation Number
Classification Product Code	DAP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/30/2009
Decision Date	10/29/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review