FDA 510(k) Application Details - K061239

Device Classification Name	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2   More FDA Info for this Device
510(K) Number	K061239
Device Name	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Applicant	EUROIMMUN US LLC 429 ROCKAWAY VALLEY ROAD UNIT 1200 BOONTON TOWNSHIP, NJ 07005 US Other 510(k) Applications for this Company
Contact	KATHRYN KOHL Other 510(k) Applications for this Contact
Regulation Number	866.3305   More FDA Info for this Regulation Number
Classification Product Code	MYF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/03/2006
Decision Date	06/28/2007
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