FDA 510(k) Application Details - K032850

Device Classification Name	Antibodies,Saccharomyces Cerevisiae (S.Cerevisiae)   More FDA Info for this Device
510(K) Number	K032850
Device Name	Antibodies,Saccharomyces Cerevisiae (S.Cerevisiae)
Applicant	IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR. BUFFALO, NY 14228 US Other 510(k) Applications for this Company
Contact	KEVIN LAWSON Other 510(k) Applications for this Contact
Regulation Number	866.5785   More FDA Info for this Regulation Number
Classification Product Code	NBT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/12/2003
Decision Date	03/18/2004
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