FDA 510(k) Applications Submitted by KEVIN LAWSON
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K060157 |
01/20/2006 |
IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA |
IMMCO DIAGNOSTICS, INC. |
| K101319 |
05/11/2010 |
IMMULISA DSDNA ANTIBODY ELISA |
IMMCO DIAGNOSTICS, INC. |
| K071346 |
05/14/2007 |
IMMULISA INTRINSIC FACTOR ANTIBODY ELISA |
IMMCO DIAGNOSTICS, INC. |
| K091520 |
05/22/2009 |
IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA |
IMMCO DIAGNOSTICS, INC. |
| K091522 |
05/22/2009 |
IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA |
IMMCO DIAGNOSTICS, INC. |
| K151559 |
06/10/2015 |
ImmuLisa Enhanced Centromere Antibody ELISA |
IMMCO DIAGNOSTICS, INC. |
| K172078 |
07/10/2017 |
ImmuLisa Enhanced RNA POL III Antibody ELISA |
IMMCO Diagnostics, Inc. |
| K172254 |
07/26/2017 |
Lyme B. burgdorferi (IgM) MarStripe Test |
Trinity Biotech |
| K032571 |
08/20/2003 |
IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA |
IMMCO DIAGNOSTICS, INC. |
| K092599 |
08/24/2009 |
IMMULISA MPO ANTIBODY ELISA |
IMMCO DIAGNOSTICS, INC. |
| K092600 |
08/24/2009 |
IMMULISA PR3 ANTIBODY ELISA |
IMMCO DIAGNOSTICS, INC. |
| K092601 |
08/24/2009 |
IMMULISA ANCA SCREEN ELISA |
IMMCO DIAGNOSTICS, INC. |
| K992878 |
08/26/1999 |
ANTI-TISSUE TRANSGLUTAMINASE (TTG)ANTIBODY TEST |
IMMCO DIAGNOSTICS, INC. |
| K032850 |
09/12/2003 |
IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG) |
IMMCO DIAGNOSTICS, INC. |
| K172745 |
09/12/2017 |
ImmuGlo HEp-2 Elite IFA |
IMMCO Diagnostics, Inc. |
| K142781 |
09/26/2014 |
ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA |
IMMCO DIAGNOSTICS, INC. |
| K162788 |
10/03/2016 |
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 |
IMMCO DIAGNOSTICS, INC. |
| K163095 |
11/04/2016 |
Lyme B. burgdorferi (IgG) MarStripe Test |
Trinity Biotech |
| K163133 |
11/08/2016 |
ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA |
IMMCO Diagnostics, Inc. |
| K163177 |
11/14/2016 |
ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA |
IMMCO DIAGNOSTICS, INC. |
| K143736 |
12/30/2014 |
ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA |
IMMCO DIAGNOSTICS, INC. |
| K040095 |
01/20/2004 |
IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG ELISA |
IMMCO DIAGNOSTICS, INC. |
| K030701 |
03/06/2003 |
IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA |
IMMCO DIAGNOSTICS, INC. |
| K030702 |
03/06/2003 |
IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA |
IMMCO DIAGNOSTICS, INC. |
| K041102 |
04/27/2004 |
IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA |
IMMCO DIAGNOSTICS, INC. |
| K982898 |
08/17/1998 |
IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM |
IMMCO DIAGNOSTICS, INC. |
| K032860 |
09/12/2003 |
IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA) |
IMMCO DIAGNOSTICS, INC. |
| K113020 |
10/11/2011 |
IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS |
IMMCO DIAGNOSTICS, INC. |
| K113143 |
10/25/2011 |
IMMULISA SCI-70 ANTIBODY ELISA |
IMMCO DIAGNOSTICS, INC. |
| K123713 |
12/04/2012 |
IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA |
IMMCO DIAGNOSTICS, INC. |
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