FDA 510(k) Application Details - K964296

Device Classification Name	Alpha-1-Lipoprotein, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K964296
Device Name	Alpha-1-Lipoprotein, Antigen, Antiserum, Control
Applicant	CRESTAT DIAGNOSTICS, INC. 25549 ADAMS AVE. MURRIETA, CA 92562 US Other 510(k) Applications for this Company
Regulation Number	866.5580   More FDA Info for this Regulation Number
Classification Product Code	DER Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/29/1996
Decision Date	08/01/1997
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