510(k) Report

Devices descending from K093582

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133284Elecsys CK-MB Calcheck 5Roche Diagnostics20134—
+2K142127Elecsys Estradiol Iii Calcheck 5Roche Diagnostics20143—
+3K150955Elecsys Progesterone III Cal Check 5Roche Diagnostics20152—
+4K162173Elecsys CYFRA 21-1 CalCheck 5Roche Diagnostics20170—
+4K160729Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5Roche Diagnostics201601