FDA 510(k) Application Details - K052439

Device Classification Name	Antibodies, Gliadin   More FDA Info for this Device
510(K) Number	K052439
Device Name	Antibodies, Gliadin
Applicant	AESKU.DIAGNOSTICS 8880 NW 18TH TERRACE MIAMI, FL 33172 US Other 510(k) Applications for this Company
Contact	STANLEY AMMONS 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	09/06/2005
Decision Date	02/07/2006
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