FDA 510(k) Application Details - K062543

Device Classification Name	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1   More FDA Info for this Device
510(K) Number	K062543
Device Name	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Applicant	FOCUS DIAGNOSTICS, INC. 10703 PROGRESS WAY CYPRESS, CA 90630-4737 US Other 510(k) Applications for this Company
Contact	MICHEAL J WAGNER,ESQ. Other 510(k) Applications for this Contact
Regulation Number	866.3305   More FDA Info for this Regulation Number
Classification Product Code	MXJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/30/2006
Decision Date	02/01/2007
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