510(k) Report

Devices descending from K854852

3 later devices reach Wellcogen Bacterial Antigen Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012521Binax Now Streptococcus Pneumoniae TestBinax, Inc.200111
+1K991726Binax Nowr Streptococcus Pneumoniae Urinary Antigen Test (22 Test Kit),(12 Test Kit)…Binax, Inc.19991—
+2K191184ImmuView S pneumoniae and L pneumophila Urinary Antigen TestSsi Diagnostica A/S20200—