FDA 510(k) Application Details - K081248

Device Classification Name	Antibodies, Outer-Membrane Proteins   More FDA Info for this Device
510(K) Number	K081248
Device Name	Antibodies, Outer-Membrane Proteins
Applicant	INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. SAN DIEGO, CA 92131-1638 US Other 510(k) Applications for this Company
Contact	ZAKERA SHUMS Other 510(k) Applications for this Contact
Regulation Number	866.5785   More FDA Info for this Regulation Number
Classification Product Code	OKM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/02/2008
Decision Date	10/27/2008
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	N
Expedited Review