510(k) Report

Devices descending from K070522

1 later device reach Modification to: Binax Now Legionella Urinary Antigen Test, #852-000,852-012 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191184ImmuView S pneumoniae and L pneumophila Urinary Antigen TestSsi Diagnostica A/S20200—