510(k) Report

Devices descending from K982238

3 later devices reach Binax Now Legionella Urinary Antigen Test Model 852-020 and Binax Now Leg… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191184ImmuView S pneumoniae and L pneumophila Urinary Antigen TestSsi Diagnostica A/S20200—
+1K113190Tru LegionellaMeridian Bioscience, Inc.20120—
+1K070522Modification to: Binax Now Legionella Urinary Antigen Test, #852-000,852-012Inverness Medical Professional Diagnostics20071—