FDA 510(k) Application Details - K063498

Device Classification Name	Alpha-1-Antitrypsin Kit, Qualitative Phenotype   More FDA Info for this Device
510(K) Number	K063498
Device Name	Alpha-1-Antitrypsin Kit, Qualitative Phenotype
Applicant	SEBIA 55 NORTHERN BLVD., SUITE 200 GREAT NECK, NY 11001 US Other 510(k) Applications for this Company
Contact	KAREN ANDERSON Other 510(k) Applications for this Contact
Regulation Number	866.5130   More FDA Info for this Regulation Number
Classification Product Code	OBZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/20/2006
Decision Date	06/11/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review