FDA 510(k) Applications for Medical Device Product Code: NBT (Antibodies,Saccharomyces Cerevisiae (S.Cerevisiae))

FDA 510(k) Applications for Medical Device Product Code "NBT"
(Antibodies,Saccharomyces Cerevisiae (S.Cerevisiae))

FDA 510(k) Number	Applicant	Device Name	Decision Date
K051492	AESKU.INC	AESKULISA ASCA A	11/14/2005
K032860	IMMCO DIAGNOSTICS, INC.	IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA)	03/18/2004
K032850	IMMCO DIAGNOSTICS, INC.	IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG)	03/18/2004
K000733	INOVA DIAGNOSTICS, INC.	QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA	05/21/2001
DEN000007	INOVA DIAGNOSTICS, INC.	QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA	08/16/2000
K071711	TECHLAB INC., CORPORATE RESEARCH CENTER	ASCA-CHEK	11/07/2007
K051927	TECHLAB, INC.	TECHLAB ASCA-CHEK	04/06/2006
K042579	THE BINDING SITE	BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT	07/28/2005