510(k) Report

Devices descending from K010314

3 later devices reach Dimension Ctni Calibrator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053577Dimension Vista Ctni Flex Flex Reagent Cartridge, Calibrator and Sdil Sample DiluentDade Behring, Inc.20062—
+2K081683Loci Cardiac Troponin I Calibrator, Model RC621Siemens Healthcare Diagnostics200803
+2K081643Dimension Tni Flex Reagent Cartridge, and Ctni Sample Diluent with Models, RF621, KD692Siemens Healthcare Diagnostics200804