510(k) Report

Devices descending from K934965

4 later devices reach Binax Legionella Urinary Antigen Eia through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K982238Binax Now Legionella Urinary Antigen Test Model 852-020 and Binax Now Leg Ionella…Binax, Inc.199831
+2K191184ImmuView S pneumoniae and L pneumophila Urinary Antigen TestSsi Diagnostica A/S20200—
+2K113190Tru LegionellaMeridian Bioscience, Inc.20120—
+2K070522Modification to: Binax Now Legionella Urinary Antigen Test, #852-000,852-012Inverness Medical Professional Diagnostics20071—