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Immco Diagnostics, Inc.

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories6
Latest FDA decision2018-06-05
TypeNumberDevice NameCodeDateActions
510(k) K172745 ImmuGlo HEp-2 Elite IFADHN2018-06-05 View
510(k) K172078 ImmuLisa Enhanced RNA POL III Antibody ELISANYO2018-03-30 View
510(k) K163133 ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISADBM2017-08-08 View
510(k) K163177 ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISAMST2017-07-28 View
510(k) K162788 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 ELISAMSV2017-06-19 View
510(k) K151559 ImmuLisa Enhanced Centromere Antibody ELISALJM2016-03-11 View