FDA 510(k) Application Details - K965100

Device Classification Name	Alpha-1-Antitrypsin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K965100
Device Name	Alpha-1-Antitrypsin, Antigen, Antiserum, Control
Applicant	CRESTAT DIAGNOSTICS, INC. 374 GOODHILL RD. WESTON, CT 06883 US Other 510(k) Applications for this Company
Contact	MARY REES 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	12/20/1996
Decision Date	07/14/1997
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