510(k) Report

Devices descending from K041357

2 later devices reach Varelisa Gliadin Igg Antibodies through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063775Elia Gliadin Iga, Igg and Celiac ControlPhadia US, Inc.20070—
+1K053383Fidis CeliacBiomedical Diagnostics (Bmd) SA20060—