FDA 510(k) Application Details - K043067

Device Classification Name	Extractable Antinuclear Antibody, Antigen And Control   More FDA Info for this Device
510(K) Number	K043067
Device Name	Extractable Antinuclear Antibody, Antigen And Control
Applicant	BIOARRAY SOLUTIONS LTD 35 TECHNOLOGY DRIVE SUITE 100 WARREN, NJ 07059 US Other 510(k) Applications for this Company
Contact	KEVIN WYCKOFF Other 510(k) Applications for this Contact
Regulation Number	866.5100   More FDA Info for this Regulation Number
Classification Product Code	LLL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/08/2004
Decision Date	05/31/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review