510(k) Report

Devices descending from K241240

4 later devices reach Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243400cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid testRoche Molecular Systems, Inc.20250—
+1K243406cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid testRoche Molecular Systems, Inc.20250—
+1K242465Panther Fusion SARS-CoV-2/Flu A/B/RSV assayHologic, Inc.20241—
+2K252387Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV…Diasorin Molecular, LLC20250—