510(k) Report

Devices descending from K221460

1 later device reach BioFire COVID-19 Test 2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230956BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD…Bd Integrated Diagnostic Solutions /20230—