510(k) Report

Devices descending from K133284

4 later devices reach Elecsys CK-MB Calcheck 5 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142127Elecsys Estradiol Iii Calcheck 5Roche Diagnostics20143—
+2K150955Elecsys Progesterone III Cal Check 5Roche Diagnostics20152—
+3K162173Elecsys CYFRA 21-1 CalCheck 5Roche Diagnostics20170—
+3K160729Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5Roche Diagnostics201601