510(k) Report

Devices descending from K053577

2 later devices reach Dimension Vista Ctni Flex Flex Reagent Cartridge, Calibrator and Sdil Sample… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081683Loci Cardiac Troponin I Calibrator, Model RC621Siemens Healthcare Diagnostics200803
+1K081643Dimension Tni Flex Reagent Cartridge, and Ctni Sample Diluent with Models, RF621, KD692Siemens Healthcare Diagnostics200804