FDA 510(k) Application Details - K012755

Device Classification Name	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K012755
Device Name	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Applicant	XTRANA, INC. 6025 NICOLLE ST. VENTURA, CA US Other 510(k) Applications for this Company
Contact	PATRICK J O'LEARY 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	08/16/2001
Decision Date	03/15/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review