FDA 510(k) Application Details - K972640

Device Classification Name	Alpha-1-Antitrypsin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K972640
Device Name	Alpha-1-Antitrypsin, Antigen, Antiserum, Control
Applicant	BOEHRINGER MANNHEIM CORP. 2380A BISSO LN. CONCORD, CA 94520 US Other 510(k) Applications for this Company
Contact	MARY KONING 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	07/15/1997
Decision Date	01/09/1998
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