510(k) Report

Devices descending from K973973

3 later devices reach Elecsys Callcheck Digoxin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102044Elecsys Digoxin Calcheck 5Roche Diagnostics20102—
+2K140267Advia Centaur Tni-Ultra Master Curve Material (MCM), Advia Centaur Digoxin Master Curve…Siemens Healthcare Diagnostics, Inc.20140—
+2K112113Elecsys Myoglobin Calcheck 5Roche Diagnostics20110—