Immco Diagnostics, Inc.
Medical device manufacturer in Buffalo, NY.
55510(k) clearances
0PMA approvals
0recalls
Device types
- LLL Extractable Antinuclear Antibody, Antigen… 8
- MVM Autoantibodies, Endomysial(Tissue… 6
- DBL Multiple Autoantibodies, Indirect… 5
- MID System, Test, Anticardiolipin Immunological 5
- MOB Test System, Antineutrophil Cytoplasmic… 4
- MST Antibodies, Gliadin 4
- MSV System,Test,Antibodies,B2 - Glycoprotein I… 3
- LJM Antinuclear Antibody (Enzyme-Labeled)… 3
- LKJ Antinuclear Antibody, Antigen, Control 2
- NBT Antibodies, Saccharomyces Cerevisiae… 2
- JZO System, Test, Thyroid Autoantibody 2
- DHR System, Test, Rheumatoid Factor 2
- DHN Antinuclear Antibody, Indirect… 2
- LSW Anti-Dna Antibody, Antigen And Control 1
- LKI Antisera, Fluorescent, Chlamydia Spp. 1
- LKO Anti-Rnp Antibody, Antigen And Control 1
- LIG Radioassay, Intrinsic Factor Blocking… 1
- LRM Anti-Dna Antibody (Enzyme-Labeled)… 1
- DBM Antimitochondrial Antibody, Indirect… 1
- NYO Autoantibodies, Anti-Ribonucleic Acid… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K172745 | ImmuGlo HEp-2 Elite IFADHN · Traditional | 06/05/2018SE |
| K172078 | ImmuLisa Enhanced RNA POL III Antibody ELISANYO · Traditional | 03/30/2018SE |
| K163133 | ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISADBM · Traditional | 08/08/2017SE |
| K163177 | ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISAMST · Traditional | 07/28/2017SE |
| K162788 | ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA…MSV · Traditional | 06/19/2017SE |
| K151559 | ImmuLisa Enhanced Centromere Antibody ELISALJM · Traditional | 03/11/2016SE |
| K143736 | ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA…DHR · Traditional | 09/23/2015SE |
| K142781 | ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA…LLL · Traditional | 03/31/2015SE |
| K123713 | Immulisa Enhanced Celiac Fusion (Ttg/Dgp) Iga/Igg Antibody ElisaMVM · Traditional | 10/25/2013SE |
| K113020 | Immulisa Enhanced (TM) Cardiolipin Iga, Igg, Igm and Iga/Igg/Igm Antibody (Aca) ElisasMID · Traditional | 10/25/2012SE |
| K113143 | Immulisa SCI-70 Antibody ElisaLLL · Traditional | 12/02/2011SE |
| K101319 | Immulisa Dsdna Antibody ElisaLRM · Traditional | 12/09/2010SE |
| K092601 | Immulisa Anca Screen ElisaMOB · Traditional | 10/07/2010SE |
| K092600 | Immulisa PR3 Antibody ElisaMOB · Traditional | 10/07/2010SE |
| K092599 | Immulisa Mpo Antibody ElisaMOB · Traditional | 10/07/2010SE |
| K091520 | Immulisa Celiac TTG Iga and Igg Antibody ElisaMVM · Traditional | 03/10/2010SE |
| K091522 | Immulisa Celiac G+ (Gliadin) Iga and Igg Antibody ElisaMST · Traditional | 02/04/2010SE |
| K071346 | Immulisa Intrinsic Factor Antibody ElisaLIG · Traditional | 09/24/2007SE |
| K060157 | Immuglo Anti-Endomysial Antibody IfaMVM · Traditional | 05/25/2006SE |
| K041102 | Immulisa Antinuclear Antibody Screen ElisaLJM · Traditional | 10/26/2004SE |
| K032860 | Immulisa Anti-Saccharomyces Cerevisiae Antibody (Asca) (Iga)NBT · Traditional | 03/18/2004SE |
| K032850 | Immulisa Anti-Saccharomyces Cerevisiae Antibody (Asca) (Igg)NBT · Traditional | 03/18/2004SE |
| K040095 | Immulisa Anti-Human Tissue Transglutaminase (Hu-Ttg) Antibody Total Iga/Igg ElisaMVM · Traditional | 03/05/2004SE |
| K032571 | Immulisa Anti-Human Tissue Transglutaminase (Hu-Ttg) Antibody Iga ElisaMVM · Traditional | 12/24/2003SE |
| K030702 | Immulisa ANTI-BETA2 Glycoprotein I (B2GP1) Igm ElisaMSV · Traditional | 09/09/2003SE |
| K030701 | Immulisa ANTI-BETA2 Glycoprotein I (B2GP1) Igg ElisaMSV · Traditional | 09/09/2003SE |
| K992878 | Anti-Tissue Transglutaminase (Ttg)Antibody TestMVM · Traditional | 10/15/1999SE |
| K982898 | Immuglo Anti-Neutrophil Cytoplasmic Antibody (Anca) Test SytemMOB · Traditional | 11/30/1998SE |
| K970177 | Anti-Cardiolipin Antibody (Aca) Screen ElisaMID · Traditional | 06/11/1997SE |
| K964344 | Igg Anti-Gliadin (Igg-Aga) Antibody Test KitMST · Traditional | 05/30/1997SE |
| K964341 | Iga Anti-Gliadin (Iga-Aga) Antibody Test KitMST · Traditional | 05/30/1997SE |
| K960370 | Thyroglobulin Antibody ElisaJZO · Traditional | 06/20/1996SE |
| K960369 | Thyroid Peroxidase Antibody ElisaJZO · Traditional | 06/20/1996SE |
| K933788 | Anti-Cardiolipin Antibody (Igm-Aca) TestMID · Traditional | 03/07/1995SE |
| K933786 | Anti-Cardiolipin Antibody (Igg-Aca) TestMID · Traditional | 03/07/1995SE |
| K933784 | Anti-Cardiolipin Antibody (Iga-Aca)Test)MID · Traditional | 03/07/1995SE |
| K943585 | Anti-Histone Anibody TestLJM · Traditional | 01/20/1995SE |
| K942272 | Igm Rheumatoid FactorDHR · Traditional | 09/26/1994SE |
| K913360 | Anti-Reticulin Antibody (Ara) TestDBL · Traditional | 09/26/1994SE |
| K912551 | Anti-Endomysial Antibody TestDBL · Traditional | 06/09/1993SE |
| K921658 | Anti-Dsdna Antibody TestLSW · Traditional | 03/22/1993SE |
| K920386 | Anti-Ena Antibody Test KitLLL · Traditional | 03/30/1992SE |
| K920385 | Anti-Ena Antibody Test (SM)LLL · Traditional | 03/30/1992SE |
| K920384 | Anit-Ena Antibody Test [Ss-B (La)]LLL · Traditional | 03/30/1992SE |
| K920383 | Anti-Ena Antibody Test [Ss-A (Ro)]LLL · Traditional | 03/30/1992SE |
| K905531 | Lupus(Le)-Latex TestLKI · Traditional | 01/25/1991SE |
| K903314 | ANTI-SCI-70 Antibody TestLLL · Traditional | 08/14/1990SE |
| K895338 | Anti-Rnp and Anti-Sm Antibody TestLKO · Traditional | 10/17/1989SE |
| K895339 | Anti-Ss-A (Ro) and Anti-Ss-B (la) Antibody TestLLL · Traditional | 10/04/1989SE |
| K891099 | Anti-Skin Antibody Test(Monkey/Guin Pig Esoph Sec)DBL · Traditional | 03/22/1989SE |
| K891098 | Anti-Skin Antibody Test(Monkey Esophagus Sections)DBL · Traditional | 03/22/1989SE |
| K884400 | Anti-Native DNA Antibody Test (Crithidia Luciliae)DHN · Traditional | 11/04/1988SE |
| K883949 | Antinuclear Antibody (Ana) Test (Mouse Liver Sect)LKJ · Traditional | 10/27/1988SE |
| K883883 | Antinuclear Antibody (Ana) Test (HEP-2 Cells)LKJ · Traditional | 10/27/1988SE |
| K883915 | Autoantibody Test System (Mouse Kidney/Stomach)DBL · Traditional | 10/19/1988SE |