FDA 510(k) Application Details - K964985

Device Classification Name	Antibodies, Gliadin   More FDA Info for this Device
510(K) Number	K964985
Device Name	Antibodies, Gliadin
Applicant	INOVA DIAGNOSTICS, INC. 10451 ROSELLE ST. SAN DIEGO, CA 92121 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	12/13/1996
Decision Date	05/30/1997
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