510(k) Report

Devices descending from K242465

1 later device reach Panther Fusion SARS-CoV-2/Flu A/B/RSV assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252387Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV…Diasorin Molecular, LLC20250—