510(k) Report

Devices descending from K102044

2 later devices reach Elecsys Digoxin Calcheck 5 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140267Advia Centaur Tni-Ultra Master Curve Material (MCM), Advia Centaur Digoxin Master Curve…Siemens Healthcare Diagnostics, Inc.20140—
+1K112113Elecsys Myoglobin Calcheck 5Roche Diagnostics20110—