510(k) Report

Devices descending from K052143

7 later devices reach Quanta Lite Gliadin Iga II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140691IG_Plex Celiac DGP PanelSqi Diagnostics Systems, Inc.20140—
+1K130053Bioplex 2200 Celiac Iga and Igg Kits on the Bioplex 2200 System, Bioplex 2200 Celiac Iga…Bio-Rad Laboratories, Inc.20130—
+1K113863Quanta Flash DGP Iga, Quanta Flash DGP Igg, Quanta Flash DGP Iga Calibrators, Quanta…Inova Diagnostics, Inc.20122—
+1K093459Elia Gliadin DP Iga Immunoassay and Elia Gliadin DP Igg Immunoassay, Models 14-5538-01…Phadia US, Inc.201012
+2K200230Aptiva Celiac Disease IgG ReagentInova Diagnostics, Inc.20210—
+2K193604Aptiva Celiac Disease IgA ReagentInova Diagnostics, Inc.20210—
+2K181871EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG…Phadia AB20190—