FDA 510(k) Application Details - K052142

Device Classification Name	Antibodies, Gliadin   More FDA Info for this Device
510(K) Number	K052142
Device Name	Antibodies, Gliadin
Applicant	INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. SAN DIEGO, CA 92131-1638 US Other 510(k) Applications for this Company
Contact	BRYS C MYERS Other 510(k) Applications for this Contact
Regulation Number	866.5750   More FDA Info for this Regulation Number
Classification Product Code	MST Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/08/2005
Decision Date	10/04/2005
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