FDA 510(k) Application Details - K961544

Device Classification Name	Whole Human Serum, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K961544
Device Name	Whole Human Serum, Antigen, Antiserum, Control
Applicant	CONSOLIDATED TECHNOLOGIES, INC. 2170 WOODWARD STREET, STE. 100 AUSTIN, TX 78744-1832 US Other 510(k) Applications for this Company
Contact	WILLIAM CONE Other 510(k) Applications for this Contact
Regulation Number	866.5700   More FDA Info for this Regulation Number
Classification Product Code	DGR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/22/1996
Decision Date	09/24/1996
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