Company ยท US
Immco Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 2018. Name variants (Inc, Corp, punctuation) are merged.
55510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 8 |
| MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 6 |
| DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | 5 |
| MID | System, Test, Anticardiolipin Immunological | 5 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 4 |
| MST | Antibodies, Gliadin | 4 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 3 |
| MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 3 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 |
| DHR | System, Test, Rheumatoid Factor | 2 |
| JZO | System, Test, Thyroid Autoantibody | 2 |
| LKJ | Antinuclear Antibody, Antigen, Control | 2 |
| NBT | Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae) | 2 |
| DBM | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | 1 |
| LIG | Radioassay, Intrinsic Factor Blocking Antibody | 1 |
| LKI | Antisera, Fluorescent, Chlamydia Spp. | 1 |
| LKO | Anti-Rnp Antibody, Antigen And Control | 1 |
| LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | 1 |
| LSW | Anti-Dna Antibody, Antigen And Control | 1 |
| NYO | Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 5, 2018 | K172745 | ImmuGlo HEp-2 Elite IFA Immco Diagnostics, Inc. | DHN |
| Mar 30, 2018 | K172078 | ImmuLisa Enhanced RNA POL III Antibody ELISA Immco Diagnostics, Inc. | NYO |
| Aug 8, 2017 | K163133 | ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA Immco Diagnostics, Inc. | DBM |
| Jul 28, 2017 | K163177 | ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA Immco Diagnostics, Inc. | MST |
| Jun 19, 2017 | K162788 | ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Anti Immco Diagnostics, Inc. | MSV |
| Mar 11, 2016 | K151559 | ImmuLisa Enhanced Centromere Antibody ELISA Immco Diagnostics, Inc. | LJM |
| Sep 23, 2015 | K143736 | ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELIS Immco Diagnostics, Inc. | DHR |
| Mar 31, 2015 | K142781 | ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody EL Immco Diagnostics, Inc. | LLL |
| Oct 25, 2013 | K123713 | IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA Immco Diagnostics, Inc. | MVM |
| Oct 25, 2012 | K113020 | IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS Immco Diagnostics, Inc. | MID |
| Dec 2, 2011 | K113143 | IMMULISA SCI-70 ANTIBODY ELISA Immco Diagnostics, Inc. | LLL |
| Dec 9, 2010 | K101319 | IMMULISA DSDNA ANTIBODY ELISA Immco Diagnostics, Inc. | LRM |
| Oct 7, 2010 | K092601 | IMMULISA ANCA SCREEN ELISA Immco Diagnostics, Inc. | MOB |
| Oct 7, 2010 | K092600 | IMMULISA PR3 ANTIBODY ELISA Immco Diagnostics, Inc. | MOB |
| Oct 7, 2010 | K092599 | IMMULISA MPO ANTIBODY ELISA Immco Diagnostics, Inc. | MOB |
| Mar 10, 2010 | K091520 | IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA Immco Diagnostics, Inc. | MVM |
| Feb 4, 2010 | K091522 | IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA Immco Diagnostics, Inc. | MST |
| Sep 24, 2007 | K071346 | IMMULISA INTRINSIC FACTOR ANTIBODY ELISA Immco Diagnostics, Inc. | LIG |
| May 25, 2006 | K060157 | IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA Immco Diagnostics, Inc. | MVM |
| Oct 26, 2004 | K041102 | IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA Immco Diagnostics, Inc. | LJM |
| Mar 18, 2004 | K032860 | IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA) Immco Diagnostics, Inc. | NBT |
| Mar 18, 2004 | K032850 | IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG) Immco Diagnostics, Inc. | NBT |
| Mar 5, 2004 | K040095 | IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG ELISA Immco Diagnostics, Inc. | MVM |
| Dec 24, 2003 | K032571 | IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA Immco Diagnostics, Inc. | MVM |
| Sep 9, 2003 | K030702 | IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA Immco Diagnostics, Inc. | MSV |
| Sep 9, 2003 | K030701 | IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA Immco Diagnostics, Inc. | MSV |
| Oct 15, 1999 | K992878 | ANTI-TISSUE TRANSGLUTAMINASE (TTG)ANTIBODY TEST Immco Diagnostics, Inc. | MVM |
| Nov 30, 1998 | K982898 | IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM Immco Diagnostics, Inc. | MOB |
| Jun 11, 1997 | K970177 | ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA Immco Diagnostics, Inc. | MID |
| May 30, 1997 | K964344 | IGG ANTI-GLIADIN (IGG-AGA) ANTIBODY TEST KIT Immco Diagnostics, Inc. | MST |
| May 30, 1997 | K964341 | IGA ANTI-GLIADIN (IGA-AGA) ANTIBODY TEST KIT Immco Diagnostics, Inc. | MST |
| Jun 20, 1996 | K960370 | THYROGLOBULIN ANTIBODY ELISA Immco Diagnostics, Inc. | JZO |
| Jun 20, 1996 | K960369 | THYROID PEROXIDASE ANTIBODY ELISA Immco Diagnostics, Inc. | JZO |
| Mar 7, 1995 | K933788 | ANTI-CARDIOLIPIN ANTIBODY (IGM-ACA) TEST Immco Diagnostics, Inc. | MID |
| Mar 7, 1995 | K933786 | ANTI-CARDIOLIPIN ANTIBODY (IGG-ACA) TEST Immco Diagnostics, Inc. | MID |
| Mar 7, 1995 | K933784 | ANTI-CARDIOLIPIN ANTIBODY (IGA-ACA)TEST) Immco Diagnostics, Inc. | MID |
| Jan 20, 1995 | K943585 | ANTI-HISTONE ANIBODY TEST Immco Diagnostics, Inc. | LJM |
| Sep 26, 1994 | K942272 | IGM RHEUMATOID FACTOR Immco Diagnostics, Inc. | DHR |
| Sep 26, 1994 | K913360 | ANTI-RETICULIN ANTIBODY (ARA) TEST Immco Diagnostics, Inc. | DBL |
| Jun 9, 1993 | K912551 | ANTI-ENDOMYSIAL ANTIBODY TEST Immco Diagnostics, Inc. | DBL |
| Mar 22, 1993 | K921658 | ANTI-DSDNA ANTIBODY TEST Immco Diagnostics, Inc. | LSW |
| Mar 30, 1992 | K920386 | ANTI-ENA ANTIBODY TEST KIT Immco Diagnostics, Inc. | LLL |
| Mar 30, 1992 | K920385 | ANTI-ENA ANTIBODY TEST (SM) Immco Diagnostics, Inc. | LLL |
| Mar 30, 1992 | K920384 | ANIT-ENA ANTIBODY TEST [SS-B (LA)] Immco Diagnostics, Inc. | LLL |
| Mar 30, 1992 | K920383 | ANTI-ENA ANTIBODY TEST [SS-A (RO)] Immco Diagnostics, Inc. | LLL |
| Jan 25, 1991 | K905531 | LUPUS(LE)-LATEX TEST Immco Diagnostics, Inc. | LKI |
| Aug 14, 1990 | K903314 | ANTI-SCI-70 ANTIBODY TEST Immco Diagnostics, Inc. | LLL |
| Oct 17, 1989 | K895338 | ANTI-RNP AND ANTI-SM ANTIBODY TEST Immco Diagnostics, Inc. | LKO |
| Oct 4, 1989 | K895339 | ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY TEST Immco Diagnostics, Inc. | LLL |
| Mar 22, 1989 | K891099 | ANTI-SKIN ANTIBODY TEST(MONKEY/GUIN PIG ESOPH SEC) Immco Diagnostics, Inc. | DBL |
Newest 50 of 55.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||