Immco Diagnostics, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 55
- Inspections
- 3
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K172745 | ImmuGlo HEp-2 Elite IFA | June 5, 2018 |
| K172078 | ImmuLisa Enhanced RNA POL III Antibody ELISA | March 30, 2018 |
| K163133 | ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA | August 8, 2017 |
| K163177 | ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA | July 28, 2017 |
| K162788 | ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enh | June 19, 2017 |
| K151559 | ImmuLisa Enhanced Centromere Antibody ELISA | March 11, 2016 |
| K143736 | ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced | September 23, 2015 |
| K142781 | ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enh | March 31, 2015 |
| K123713 | IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA | October 25, 2013 |
| K113020 | IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS | October 25, 2012 |
| K113143 | IMMULISA SCI-70 ANTIBODY ELISA | December 2, 2011 |
| K101319 | IMMULISA DSDNA ANTIBODY ELISA | December 9, 2010 |
| K092600 | IMMULISA PR3 ANTIBODY ELISA | October 7, 2010 |
| K092599 | IMMULISA MPO ANTIBODY ELISA | October 7, 2010 |
| K092601 | IMMULISA ANCA SCREEN ELISA | October 7, 2010 |
| K091520 | IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA | March 10, 2010 |
| K091522 | IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA | February 4, 2010 |
| K071346 | IMMULISA INTRINSIC FACTOR ANTIBODY ELISA | September 24, 2007 |
| K060157 | IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA | May 25, 2006 |
| K041102 | IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA | October 26, 2004 |