Immco Diagnostics, Inc.

Williamsville, NY, US

IMMCO DIAGNOSTICS, INC. appears in FDA device records in Williamsville, NY. FDA records list 55 510(k) clearances between 1988-10-19 and 2018-06-05, no PMA records and one registered establishment. As of 2026-09-10, FDA records show no recalls for this company, and at least one establishment registration is current.

510(k) clearances: 55
PMA records: 0
Recall records: 0
Registered establishments: 1

510(k) clearance history

Showing 50 of 55

FDA records hold 55 510(k) clearances for Immco Diagnostics, Inc. between 1988 and 2018. The busiest year on record is 2010, with 6. The most recent is 2018, with 2.

Clearances by year, as a table

510(k) clearance decisions for Immco Diagnostics, Inc., by decision year
Year	Clearances
1988	4
1989	4
1990	1
1991	1
1992	4
1993	2
1994	2
1995	4
1996	2
1997	3
1998	1
1999	1
2003	3
2004	4
2006	1
2007	1
2010	6
2011	1
2012	1
2013	1
2015	2
2016	1
2017	3
2018	2

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K172745	ImmuGlo HEp-2 Elite IFA	DHN	Substantially Equivalent	2018-06-05
K172078	ImmuLisa Enhanced RNA POL III Antibody ELISA	NYO	Substantially Equivalent	2018-03-30
K163133	ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA	DBM	Substantially Equivalent	2017-08-08
K163177	ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA	MST	Substantially Equivalent	2017-07-28
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	Substantially Equivalent	2017-06-19
K151559	ImmuLisa Enhanced Centromere Antibody ELISA	LJM	Substantially Equivalent	2016-03-11
K143736	ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA	DHR	Substantially Equivalent	2015-09-23
K142781	ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA	LLL	Substantially Equivalent	2015-03-31
K123713	IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA	MVM	Substantially Equivalent	2013-10-25
K113020	IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS	MID	Substantially Equivalent	2012-10-25
K113143	IMMULISA SCI-70 ANTIBODY ELISA	LLL	Substantially Equivalent	2011-12-02
K101319	IMMULISA DSDNA ANTIBODY ELISA	LRM	Substantially Equivalent	2010-12-09
K092601	IMMULISA ANCA SCREEN ELISA	MOB	Substantially Equivalent	2010-10-07
K092600	IMMULISA PR3 ANTIBODY ELISA	MOB	Substantially Equivalent	2010-10-07
K092599	IMMULISA MPO ANTIBODY ELISA	MOB	Substantially Equivalent	2010-10-07
K091520	IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA	MVM	Substantially Equivalent	2010-03-10
K091522	IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA	MST	Substantially Equivalent	2010-02-04
K071346	IMMULISA INTRINSIC FACTOR ANTIBODY ELISA	LIG	Substantially Equivalent	2007-09-24
K060157	IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA	MVM	Substantially Equivalent	2006-05-25
K041102	IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA	LJM	Substantially Equivalent	2004-10-26
K032860	IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA)	NBT	Substantially Equivalent	2004-03-18
K032850	IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG)	NBT	Substantially Equivalent	2004-03-18
K040095	IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG ELISA	MVM	Substantially Equivalent	2004-03-05
K032571	IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA	MVM	Substantially Equivalent	2003-12-24
K030702	IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA	MSV	Substantially Equivalent	2003-09-09
K030701	IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA	MSV	Substantially Equivalent	2003-09-09
K992878	ANTI-TISSUE TRANSGLUTAMINASE (TTG)ANTIBODY TEST	MVM	Substantially Equivalent	1999-10-15
K982898	IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM	MOB	Substantially Equivalent	1998-11-30
K970177	ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA	MID	Substantially Equivalent	1997-06-11
K964344	IGG ANTI-GLIADIN (IGG-AGA) ANTIBODY TEST KIT	MST	Substantially Equivalent	1997-05-30
K964341	IGA ANTI-GLIADIN (IGA-AGA) ANTIBODY TEST KIT	MST	Substantially Equivalent	1997-05-30
K960370	THYROGLOBULIN ANTIBODY ELISA	JZO	Substantially Equivalent	1996-06-20
K960369	THYROID PEROXIDASE ANTIBODY ELISA	JZO	Substantially Equivalent	1996-06-20
K933788	ANTI-CARDIOLIPIN ANTIBODY (IGM-ACA) TEST	MID	Substantially Equivalent	1995-03-07
K933786	ANTI-CARDIOLIPIN ANTIBODY (IGG-ACA) TEST	MID	Substantially Equivalent	1995-03-07
K933784	ANTI-CARDIOLIPIN ANTIBODY (IGA-ACA)TEST)	MID	Substantially Equivalent	1995-03-07
K943585	ANTI-HISTONE ANIBODY TEST	LJM	Substantially Equivalent	1995-01-20
K942272	IGM RHEUMATOID FACTOR	DHR	Substantially Equivalent	1994-09-26
K913360	ANTI-RETICULIN ANTIBODY (ARA) TEST	DBL	Substantially Equivalent	1994-09-26
K912551	ANTI-ENDOMYSIAL ANTIBODY TEST	DBL	Substantially Equivalent	1993-06-09
K921658	ANTI-DSDNA ANTIBODY TEST	LSW	Substantially Equivalent	1993-03-22
K920386	ANTI-ENA ANTIBODY TEST KIT	LLL	Substantially Equivalent	1992-03-30
K920385	ANTI-ENA ANTIBODY TEST (SM)	LLL	Substantially Equivalent	1992-03-30
K920384	ANIT-ENA ANTIBODY TEST [SS-B (LA)]	LLL	Substantially Equivalent	1992-03-30
K920383	ANTI-ENA ANTIBODY TEST [SS-A (RO)]	LLL	Substantially Equivalent	1992-03-30
K905531	LUPUS(LE)-LATEX TEST	LKI	Substantially Equivalent	1991-01-25
K903314	ANTI-SCI-70 ANTIBODY TEST	LLL	Substantially Equivalent	1990-08-14
K895338	ANTI-RNP AND ANTI-SM ANTIBODY TEST	LKO	Substantially Equivalent	1989-10-17
K895339	ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY TEST	LLL	Substantially Equivalent	1989-10-04
K891099	ANTI-SKIN ANTIBODY TEST(MONKEY/GUIN PIG ESOPH SEC)	DBL	Substantially Equivalent	1989-03-22

Registered establishments

FDA registered establishments for Immco Diagnostics, Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3015376545	3015376545	IMMCO DIAGNOSTICS, INC.	10 Earhart Drive, Williamsville, NY 14221 US	2026	DBL DGR DHN DHR IBK ICT JQW JSM KEQ LKJ and 9 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain