510(k) Report

Devices descending from K012521

1 later device reach Binax Now Streptococcus Pneumoniae Test through their predicates, nearest generation first.

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