510(k) Report

Devices descending from K830206

3 later devices reach TDX N-Acetylprocainamide through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K963306Cedia N-Acetylprocainamide AssayBoehringer Mannheim Corp.19960—
+1K962269Cedia Cardiac TDM Multi-CalsBoehringer Mannheim Corp.19961—
+2K972433Cedia Digoxin CalibratorsBoehringer Mannheim Corp.19970—