FDA 510(k) Application Details - K091468

Device Classification Name	Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking   More FDA Info for this Device
510(K) Number	K091468
Device Name	Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking
Applicant	IVD TECHNOLOGIES 150 CHERRY LANE ROAD EAST STROUDSBURG, PA 18301 US Other 510(k) Applications for this Company
Contact	Gary Lehnus Other 510(k) Applications for this Contact
Regulation Number	866.5660   More FDA Info for this Regulation Number
Classification Product Code	NST Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/18/2009
Decision Date	11/20/2009
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	N
Expedited Review