FDA 510(k) Application Details - K033491

Device Classification Name	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K033491
Device Name	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Applicant	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46256 US Other 510(k) Applications for this Company
Contact	JENNIFER TRIBBETT 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	11/04/2003
Decision Date	09/01/2004
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