510(k) Report

Devices descending from K113863

2 later devices reach Quanta Flash DGP Iga, Quanta Flash DGP Igg, Quanta Flash DGP Iga Calibrators… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200230Aptiva Celiac Disease IgG ReagentInova Diagnostics, Inc.20210—
+1K193604Aptiva Celiac Disease IgA ReagentInova Diagnostics, Inc.20210—