FDA 510(k) Application Details - K072901

Device Classification Name	System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer   More FDA Info for this Device
510(K) Number	K072901
Device Name	System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer
Applicant	AMDL, INC. 2492 WALNUT AVE. SUITE 100 TUSTIN, CA 92780-7039 US Other 510(k) Applications for this Company
Contact	GARY DREHER Other 510(k) Applications for this Contact
Regulation Number	866.6010   More FDA Info for this Regulation Number
Classification Product Code	NTY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/11/2007
Decision Date	07/01/2008
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