FDA 510(k) Application Details - K081104

Device Classification Name	Antinuclear Antibody, Antigen, Control   More FDA Info for this Device
510(K) Number	K081104
Device Name	Antinuclear Antibody, Antigen, Control
Applicant	AESKU.DIAGNOSTICS MIKROFORUM RING 2 WENDELSHEIM D-55234 DE Other 510(k) Applications for this Company
Contact	JIM RADFORD Other 510(k) Applications for this Contact
Regulation Number	866.5100   More FDA Info for this Regulation Number
Classification Product Code	LKJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/18/2008
Decision Date	05/02/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	Y
Expedited Review