510(k) Report

Devices descending from K910642

2 later devices reach Cedia (R) Digoxin SC Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K962269Cedia Cardiac TDM Multi-CalsBoehringer Mannheim Corp.19961—
+2K972433Cedia Digoxin CalibratorsBoehringer Mannheim Corp.19970—