FDA 510(k) Application Details - K984126

Device Classification Name	Antigen, Ebv, Capsid   More FDA Info for this Device
510(K) Number	K984126
Device Name	Antigen, Ebv, Capsid
Applicant	ZEUS SCIENTIFIC, INC. 200 EVANS WAY BRANCHBURG, NJ 08876 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	MCD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/18/1998
Decision Date	01/11/1999
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