FDA 510(k) Application Details - K042092

Device Classification Name	Antibody Igm, If, Epstein-Barr Virus   More FDA Info for this Device
510(K) Number	K042092
Device Name	Antibody Igm, If, Epstein-Barr Virus
Applicant	ZEUS SCIENTIFIC, INC. P.O. BOX 38 RARITAN, NJ 08869 US Other 510(k) Applications for this Company
Contact	MARK J KOPNITSKY 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	08/03/2004
Decision Date	04/12/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review