Immco Diagnostics, Inc.

FDA 510(k) & PMA Approved Devices — 53 products

Total Devices53

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K172745	ImmuGlo HEp-2 Elite IFA	DHN	2018-06-05	View
510(k)	K172078	ImmuLisa Enhanced RNA POL III Antibody ELISA	NYO	2018-03-30	View
510(k)	K163133	ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA	DBM	2017-08-08	View
510(k)	K163177	ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA	MST	2017-07-28	View
510(k)	K162788	ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA	MSV	2017-06-19	View
510(k)	K151559	ImmuLisa Enhanced Centromere Antibody ELISA	LJM	2016-03-11	View
510(k)	K123713	IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA	MVM	2013-10-25	View
510(k)	K113020	IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS	MID	2012-10-25	View
510(k)	K113143	IMMULISA SCI-70 ANTIBODY ELISA	LLL	2011-12-02	View
510(k)	K101319	IMMULISA DSDNA ANTIBODY ELISA	LRM	2010-12-09	View
510(k)	K092599	IMMULISA MPO ANTIBODY ELISA	MOB	2010-10-07	View
510(k)	K092601	IMMULISA ANCA SCREEN ELISA	MOB	2010-10-07	View
510(k)	K092600	IMMULISA PR3 ANTIBODY ELISA	MOB	2010-10-07	View
510(k)	K091520	IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA	MVM	2010-03-10	View
510(k)	K091522	IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA	MST	2010-02-04	View
510(k)	K071346	IMMULISA INTRINSIC FACTOR ANTIBODY ELISA	LIG	2007-09-24	View
510(k)	K060157	IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA	MVM	2006-05-25	View
510(k)	K041102	IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA	LJM	2004-10-26	View
510(k)	K032860	IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA)	NBT	2004-03-18	View
510(k)	K032850	IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG)	NBT	2004-03-18	View