510(k) Report

Devices descending from K905689

4 later devices reach Cedia Phenytoin Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K963840Cedia Phenytoin II AssayBoehringer Mannheim Corp.19961—
+1K961659Cedia Core TDM Multi-CalBoehringer Mannheim Corp.19961—
+2K120936Abbott TDM Multiconstituent Calibrator, Thermo Scientific QMS Multi-Constituent…Microgenics Corporation20120—
+2K030428Roche Online TDM PhenytoinRoche Diagnostics Corp.200302