FDA 510(k) Application Details - K052819

Device Classification Name	Alpha-1-Antitrypsin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K052819
Device Name	Alpha-1-Antitrypsin, Antigen, Antiserum, Control
Applicant	Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. ROCHESTER, NY 14626-5101 US Other 510(k) Applications for this Company
Contact	Darlene J Phillips Other 510(k) Applications for this Contact
Regulation Number	866.5130   More FDA Info for this Regulation Number
Classification Product Code	DEM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/04/2005
Decision Date	12/23/2005
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