Medical Device Manufacturer · US , Buffalo , NY

Immco Diagnostics, Inc.

55 submissions · 55 cleared · Since 1988
55
Total
55
Cleared
0
Denied

Immco Diagnostics, Inc. — FDA 510(k) Submissions

Immco Diagnostics, Inc. has submitted 55 FDA 510(k) premarket notifications since 1988, of which 55 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Extractable Antinuclear Antibody, Antigen And Control, Autoantibodies, Endomysial(tissue Transglutaminase), Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control, System, Test, Anticardiolipin Immunological, Antibodies, Gliadin . Use the specialty filter in the sidebar to narrow results.

55 devices
1–25 of 55
ImmuGlo HEp-2 Elite IFA
K172745 · DHN Antinuclear Antibody,... · Immunology
Jun 2018 266d
ImmuLisa Enhanced RNA POL III Antibody ELISA
K172078 · NYO Autoantibodies,... · Immunology
Mar 2018 263d
ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA
K163133 · DBM Antimitochondrial... · Immunology
Aug 2017 273d
ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA
K163177 · MST Antibodies, Gliadin · Immunology
Jul 2017 256d
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
K162788 · MSV System,test,antibodies,b2... · Immunology
Jun 2017 259d
ImmuLisa Enhanced Centromere Antibody ELISA
K151559 · LJM Antinuclear Antibody... · Immunology
Mar 2016 275d
ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA
K143736 · DHR System, Test, Rheumatoid... · Immunology
Sep 2015 267d
ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA
K142781 · LLL Extractable Antinuclear... · Immunology
Mar 2015 186d
IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA
K123713 · MVM Autoantibodies,... · Immunology
Oct 2013 325d
IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS
K113020 · MID System, Test,... · Immunology
Oct 2012 380d
IMMULISA SCI-70 ANTIBODY ELISA
K113143 · LLL Extractable Antinuclear... · Immunology
Dec 2011 38d
IMMULISA DSDNA ANTIBODY ELISA
K101319 · LRM Anti-dna Antibody... · Immunology
Dec 2010 212d
IMMULISA MPO ANTIBODY ELISA
K092599 · MOB Test System,... · Immunology
Oct 2010 409d
IMMULISA PR3 ANTIBODY ELISA
K092600 · MOB Test System,... · Immunology
Oct 2010 409d
IMMULISA ANCA SCREEN ELISA
K092601 · MOB Test System,... · Immunology
Oct 2010 409d
IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA
K091520 · MVM Autoantibodies,... · Immunology
Mar 2010 292d
IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA
K091522 · MST Antibodies, Gliadin · Immunology
Feb 2010 258d
IMMULISA INTRINSIC FACTOR ANTIBODY ELISA
K071346 · LIG Radioassay, Intrinsic... · Immunology
Sep 2007 133d
IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA
K060157 · MVM Autoantibodies,... · Immunology
May 2006 125d
IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA
K041102 · LJM Antinuclear Antibody... · Immunology
Oct 2004 182d
IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG)
K032850 · NBT Antibodies, Saccharomyces... · Immunology
Mar 2004 188d
IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA)
K032860 · NBT Antibodies, Saccharomyces... · Immunology
Mar 2004 188d
IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG ELISA
K040095 · MVM Autoantibodies,... · Immunology
Mar 2004 45d
IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA
K032571 · MVM Autoantibodies,... · Immunology
Dec 2003 126d
IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA
K030701 · MSV System,test,antibodies,b2... · Immunology
Sep 2003 187d
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