FDA 510(k) Application Details - K973910

Device Classification Name	Antibodies, Gliadin   More FDA Info for this Device
510(K) Number	K973910
Device Name	Antibodies, Gliadin
Applicant	GENESIS DIAGNOSTICS LTD. EDEN RESEARCH PARK HENRY CRABB RD. LITTLEPORT, CAMBRIDGESHIRE CB6 1SE GB Other 510(k) Applications for this Company
Contact	MICHAEL WALKER 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	10/14/1997
Decision Date	02/17/1999
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