FDA 510(k) Application Details - K040854

Device Classification Name	Elisa, Antibody, West Nile Virus   More FDA Info for this Device
510(K) Number	K040854
Device Name	Elisa, Antibody, West Nile Virus
Applicant	FOCUS TECHNOLOGIES, INC. 10703 PROGRESS WAY CYPRESS, CA 90630-4737 US Other 510(k) Applications for this Company
Contact	MICHAEL J WAGNER Other 510(k) Applications for this Contact
Regulation Number	866.3940   More FDA Info for this Regulation Number
Classification Product Code	NOP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/01/2004
Decision Date	06/30/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review