FDA 510(k) Application Details - K070317

Device Classification Name	Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster   More FDA Info for this Device
510(K) Number	K070317
Device Name	Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
Applicant	ZEUS SCIENTIFIC, INC. 200 EVANS WAY BRANCHBURG, NJ 08876 US Other 510(k) Applications for this Company
Contact	EWA NADOLCZAK Other 510(k) Applications for this Contact
Regulation Number	866.3900   More FDA Info for this Regulation Number
Classification Product Code	LFY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/02/2007
Decision Date	07/05/2007
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