FDA 510(k) Application Details - K073381

Device Classification Name	Antibody Igm, If, Epstein-Barr Virus   More FDA Info for this Device
510(K) Number	K073381
Device Name	Antibody Igm, If, Epstein-Barr Virus
Applicant	FOCUS DIAGNOSTICS, INC. 10703 PROGRESS WAY CYPRESS, CA 90630-4737 US Other 510(k) Applications for this Company
Contact	CONSTANCE BRIDGES Other 510(k) Applications for this Contact
Regulation Number	866.3235   More FDA Info for this Regulation Number
Classification Product Code	LJN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/03/2007
Decision Date	08/04/2008
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