510(k) Report

Devices descending from K150955

2 later devices reach Elecsys Progesterone III Cal Check 5 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162173Elecsys CYFRA 21-1 CalCheck 5Roche Diagnostics20170—
+1K160729Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5Roche Diagnostics201601