510(k) Report

Devices descending from K223591

1 later device reach cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas®… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251742VELO Respiratory TestLex Diagnostics Limited20260—